Atlas FDA

1

32,815 FDA 510(k) clearances · Device class

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
NITRILE BLUE POWDERED EXAMINATION GLOVES (K052955)Great Glove Sdn Bhd2006-01-19
C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02 (K052651)Rayner Surgical, Inc.2006-01-19
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K052729)Shijiazhuang Brilliant Ocean Plastic Co., Ltd.2006-01-19
DISPOSABLE PVC EXAMINATION GLOVE, POWDERED AND POWDER-FREE (K053259)Practical Protective Plastic Manufactory , Ltd.2006-01-18
VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET (K053247)Maine Standards Co.2006-01-13
IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES (K052741)W&H Dentalwerk Buermoos GmbH2006-01-13
POWDERED VINYL EXAMINATION GLOVE (K052984)Tg Medical (China) Incorporation2006-01-11
UROK ROCKING WHEELCHAIR, MODEL 700-4XX (K052548)Amg Medical, Inc.2006-01-06
CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES (K053272)Cardinalhealth2006-01-05
SMARTPREP2 CENTRIFUGE SYSTEM (K052925)Harvest Technologies, Corp.2006-01-04
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT (K052867)Ortho-Clinical Diagnostics, Inc.2005-12-23
NITRILE BLUE POWDER FREE EXAMINATION GLOVE (K052956)Great Glove Sdn Bhd2005-12-21
GREAT GLOVE POWDER FREE VINYL EXAMINATION GLOVES (K052923)Great Glove (China), Inc.2005-12-21
GREAT GLOVE POWDERED VINYL EXAMINATION GLOVES (K052922)Great Glove (China), Inc.2005-12-20
PANA-SPRAY (K052700)Nsk America Corp.2005-12-20
BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES (K052772)Barriermed Glove Co.2005-12-20
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873; (K052645)Ortho-Clinical Diagnostics2005-12-14
TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW (K052635)Teh Loong Corp.2005-12-13
BREATHKEY MODEL G10/BREATHKEY MODEL G30X (K052804)Omega Point Systems, LLC2005-12-09
A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P (K052586)Taiwan an I Co., Ltd.2005-12-09
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A (K053157)Dade Behring, Inc.2005-12-09
POWDER FREE STERILE LATEX SURGICAL GLOVES (K052177)Hartalega Sdn Bhd2005-12-09
ROBIN HOOD VEST (K051300)Kamber Corporation2005-12-08
INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC (K051638)Unipath , Ltd.2005-12-06
POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR (K050526)Spi Gloves Sdn. Bhd.2005-12-06
POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES (K052728)M/S. Kanam Latex Industries Pvt. , Ltd.2005-12-05
MODEL 418 SERIES WALKERS (K053192)Mjm International Corporation2005-12-05
ONE STEP FSH MENOPAUSAL TEST (K052662)Ind Diagnostic, Inc.2005-11-30
LIBERTY GLUCOSE CONTROL, MODEL 2120031 (K052980)Liberty Healthcare Group, Inc.2005-11-30
SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55 (K052892)Barriermed Glove Co.2005-11-30
ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX (K052387)Arthrex, Inc.2005-11-29
ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK (K053059)Roche Diagnostics2005-11-28
ESTEEM STRETCHY VINYL GLOVE WITH COATING (K052568)Cardinalhealth2005-11-28
SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY (K051114)Sentinel Ch. Srl2005-11-25
DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR (K052612)Shanghai Antares Industries, Inc.2005-11-22
RPS ADENO DETECTOR (K052092)Rapid Pathogen Screening2005-11-22
SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA (K052837)Terang Nusa Sdn Bhd2005-11-21
NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ (K052099)Polyganics B.V.,2005-11-21
NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES (K052502)Yty Industry (Manjung) Sdn Bhd2005-11-18
CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E (K052679)Cliniqa Corporation2005-11-18
SENTINEL UIBC LIQUID (K051111)Sentinel Ch. Srl2005-11-17
TEH LOONG POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW (K052636)Teh Loong Corp.2005-11-10
MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED) (K051082)Medtrade Products , Ltd.2005-11-08
POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE (K052877)Syntex Healthcare Products Co., Ltd.2005-11-08
POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE (K052709)Pt.Shamrock Manufacturing Corp.2005-11-08
ABSOLUTE AMERICA (K050571)Eurodent S.P.A.2005-11-02
F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT (K052470)Shanghai Fimet Medical Instrument Co., Ltd.2005-11-01
PATHFORMER (K052770)Path Scientific, LLC2005-10-31
NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E (K052890)Siam Sempermed Corp., Ltd.2005-10-31
CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 (K052473)Inter Medical Medizintechnik GmbH2005-10-28
AIMSTICK URINE REAGENT STRIPS (K051727)Germaine Laboratories, Inc.2005-10-26
DEUTSCH ANTI-BLOCKAGE WOUND DRAIN (K052286)The Catheter Exchange, Inc.2005-10-21
NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR (K051562)Terang Nusa Sdn Bhd2005-10-20
QUICKSMILE (K052040)Cosmetic Dental Materials, Inc.2005-10-18
NEWGEL AND NEWGEL PLUS E (K041704)Newmedical Technology, Inc.2005-10-17
ELECSYS PRECICONTROL BONE (K051543)Roche Diagnostics Corp.2005-10-17
AUTOCHECK6+ (K051928)Radiometer Medical Aps2005-10-12
TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE (K052634)Teh Loong Corp.2005-10-11
FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE (K051987)Pt. Mandiri Inti Buana2005-10-06
START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI) (K052681)Otto Bock Healthcare LP2005-10-06
YK9000 SERIES MANUAL WHEELCHAIR (K052468)Intco Metal Products (Zhenjiang) Co., Ltd.2005-10-05
HBA1C LINEARITY SET (K052010)Cone Bioproducts2005-10-04
ADVIA CHEMISTRY MICROALBUMIN CONTROLS (K052242)Bayer Healthcare, LLC2005-10-03
MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 (K051872)Mk-Dent GmbH2005-10-03
TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA (K051969)Ibl GmbH2005-10-03
POWDERED LATEX PATIENT EXAMINATION GLOVES (K051913)Shinemound Enterprise, Inc.2005-09-30
POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE (K052273)Pt Mahakarya Inti Buana2005-09-30
B-CARE POWDER FREE LATEX EXAMINATION GLOVES (K051404)B-Care Industries Co., Ltd.2005-09-27
SYRYKER SORANO WHEELCHAIR (K051369)Stryker Canada2005-09-26
NISSIN SERIES MECHANICAL WHEELCHAIR (K052521)Nissin Medical Industries Co., Ltd.2005-09-26
DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM (K052056)Thermo-Electron Corp.2005-09-23
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K052382)Pt.Shamrock Manufacturing Corp.2005-09-15
EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 (K050524)Marda Medical, Inc.2005-09-14
PRE-POWDERED STERILE EXAM GLOVES (K052214)Kanam Latex Industries Pvt. , Ltd.2005-09-13
SURGEON'S GLOVE, POWDER FREE (K052030)Shun Thai Rubber Gloves Industry Public Co., Ltd.2005-09-13
POWDERED LATEX SURGEON'S GLOVE (K052031)Shun Thai Rubber Gloves Industry Public Co., Ltd.2005-09-12
THE NEEDLE CATCHER (K051281)E.D.Medical , Ltd.2005-09-08
PARALLAX EZFLOW CEMENT DELIVERY SYSTEM (K051820)Arthrocare Corp.2005-09-06
IMPLANT HANDPIECES (K051661)Sirona Dental Systems GmbH2005-09-06
POWDERED VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE, YELLOW) (K051924)Shijiazhuang Manful Light Industrial Products Co.,2005-09-02
ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM (K050411)Zimmer, Inc.2005-09-02
IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT (K050352)Ameritek Research, LLC2005-09-01
NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING (K052016)Sgmp Co., Ltd.2005-09-01
RELIEVA SINUS BALLOON INFLATION DEVICE (K052198)Acclarent, Inc.2005-08-31
A-DEC SELF-CONTAINED WATER SYSTEM (K051657)A-Dec, Inc.2005-08-30
SENTINEL IRON LIQUID (K051115)Sentinel Ch. Srl2005-08-25
ULTRA HDL (K051962)Abbott Laboratories2005-08-25
OPD-STATION SOFTWARE (K050336)Nidek, Inc.2005-08-24
ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE (K051376)Roche Diagnostics2005-08-23
ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE) (K051793)Ansell Healthcare Products, LLC2005-08-17
URITEK-720+ URINE ANALYZER (K051526)Teco Diagnostics2005-08-16
POWDERED VINYL PATIENT EXAMINATION GLOVES WHITE (NON-COLORED) (K051923)Shijiazhuang Wonder Plastic Co., Ltd.2005-08-16
C CHANGE SOLUTION WARMER (K051819)C Change Surgical, LLC2005-08-15
FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM (K050575)Futumeds Sdn Bhd2005-08-15
EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR (K051302)Medline Industries, Inc.2005-08-15
BIOGEL LATEX STERILE POWDER-FREE GLOVE (K050899)Regent Medical Americas, LLC2005-08-12
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) (K051777)Hartalega Sdn Bhd2005-08-12
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK (K052053)Bio-Rad2005-08-09
SLIVASURE (K051409)Scandinavian Formulas, Inc.2005-08-08
DIRECT LDL CHOLESTEROL, MODEL L530-60H (K051121)Teco Diagnostics2005-08-08
← Previous Next →

Track 1 automatically

Every clearance here is in the API, with alerts when new ones post.