Atlas FDA

2000

3,453 FDA 510(k) clearances · Clearance year

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
REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE) (K991677)London International Group, Inc.2000-04-12
NITRILE EXAM GLOVE, POWDER FREE, BLUE (K000670)Shasta Asia Partners Gloves Manufacturing CO , Ltd.2000-04-12
VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K000391)Sgmp Co., Ltd.2000-04-12
VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K000390)Sgmp Co., Ltd.2000-04-12
VIP- VARIABLE INTENSITY POLYMERIZER (K000426)Bisco, Inc.2000-04-12
TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O (K000555)Tekmedic (M) Sdn Bhd2000-04-12
MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS (K990830)Biomet, Inc.2000-04-11
OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM (K000415)Optimal Imaging Systems, Inc.2000-04-11
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (K000768)Wallach Surgical Devices, Inc.2000-04-11
RGP MULTI-PURPOSE SOLUTION ID 100136 (K000148)Alcon Laboratories2000-04-11
POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C (K972610)Possis Medical, Inc.2000-04-11
SAMPLOK (K000777)Itl Corporation Pty, Ltd.2000-04-11
HONIGUM (K000878)Dmg USA, Inc.2000-04-11
BODYGUARD (K000441)Vital Signs, Inc.2000-04-11
SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM (K000221)Ge Dec Medical Systems2000-04-11
SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST (K000350)Drug Detection Devices, Ltd.2000-04-11
MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES (K000345)Medical Advances, Inc.2000-04-11
CORTEK ARTHROSCOPE (K000198)Cortek Endoscopy, Inc.2000-04-11
FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT (K000471)Future Diagnostics B.V.2000-04-11
REDI-SCREEN (K000979)Redwood Biotech, Inc.2000-04-10
5.0MM SPINAL SCREWS (K994288)Ortho Tec, LLC2000-04-10
TRANSLUMINAL BALLOON DILATATION CATHETER (K993305)Boston Scientific Corp2000-04-10
MODIFICATION TO JMS APHERESIS NEEDLE (K000843)Jms Co., Ltd.2000-04-10
BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K000652)Betel Care Sdn. Bhd.2000-04-10
HMS NEUROMUSCULAR STIMULATOR (K994062)Home Medical Services, Inc.2000-04-10
CARDIO-CARD INTERPRETATION SYSTEM I (K993616)Nasiff Assoc., Inc.2000-04-10
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER (K000854)Agilent Technologies, Inc.2000-04-10
PRO.DUCT CATHETER, MODEL CTH03 (K000135)Pro. Duct Health, Inc.2000-04-10
PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM (K993272)Pure Water, Inc.2000-04-10
BAYER ADVIA IMS SYSTEM (K993867)Bayer Corp.2000-04-10
MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254 (K991458)Matsushita Electric Corp. of America2000-04-10
E3 MICROPROB SERIES OF LASERS AND ACCESSORIES (K000192)Martin Uram, MD2000-04-10
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS (K993448)Ela Medical, Inc.2000-04-10
PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE (K000151)Integrated Orbital Implants, Inc.2000-04-10
DIGITAL INFLECTION RIGIDOMETER (DIR) (K000194)Uroan Xxi Electromedicina2000-04-10
SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS (K000410)Beckman Coulter, Inc.2000-04-10
MODIFICATION TO MARSPO2, MODEL 2001 (K000794)Novametrix Medical Systems, Inc.2000-04-10
MODIFICATION TO JMS A.V. FISTULA NEEDLE SET (K000845)Jms Co., Ltd.2000-04-10
HEMISPHERE MODULAR CUP SYSTEM (K000321)Ortho Development Corp.2000-04-10
HARDYDISK, AMPICILLIN, 10MCG (K000268)Hardy Diagnostics2000-04-07
SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST (K000449)Drug Detection Devices, Ltd.2000-04-07
PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 (K993414)Prucka Engineering, Inc.2000-04-07
HARDYDISK CEFTRIAXONE 30MCG (K000440)Hardy Diagnostics2000-04-07
RENEGADE HI-FLO MICROCATHETER (K000177)Boston Scientific Corp2000-04-07
KFA-63 KNEE AND FOOT ARRAY (K000935)Mri Devices Corp.2000-04-07
HARDYDISK OFLOXACIN 5MCG (K000525)Hardy Diagnostics2000-04-07
FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX (K000746)Fukuda Denshi USA, Inc.2000-04-07
MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT (K000061)Minxray, Inc.2000-04-07
ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM (K993923)Adac Laboratories2000-04-07
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 (K000528)Sigma Diagnostics, Inc.2000-04-07
HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG (K000261)Hardy Diagnostics2000-04-07
MDI SCL-70 TEST (K000934)Micro Detect, Inc.2000-04-07
SIPHONGUARD CSF CONTROL DEVICE (K992173)Johnson & Johnson Professionals, Inc.2000-04-07
ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595 (K994165)Roche Diagnostics Corp.2000-04-07
HARDYDISK, VANCOMYCIN 30MCG (K000509)Hardy Diagnostics2000-04-07
HARDYDISK, CEFOTAXIME 30MCG (K000524)Hardy Diagnostics2000-04-07
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 (K000527)Sigma Diagnostics, Inc.2000-04-07
SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST (K000273)Drug Detection Devices, Ltd.2000-04-07
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE (K000828)Pamitex Industries Sdn Bhd2000-04-07
HARDYDISK, NITROFURANTOIN (K000272)Hardy Diagnostics2000-04-07
HARDYDISK, SULFA/TRIMETH (K000271)Hardy Diagnostics2000-04-07
ESKA MODULAR HIP SYSTEM (K993027)Specs USA, Inc.2000-04-06
JELDENT BASIC LINE (K000213)J.F. Jelenko & Co.2000-04-06
PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 (K000763)Biotronik, GmbH & Co.2000-04-06
ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 (K991060)Zcv ,Inc.2000-04-06
CORDIS 13F CATHETER SHEATH INTRODUCER (K000753)Cordis Corp.2000-04-06
AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR (K000822)Agilent Technologies, GmbH2000-04-06
STERLTECH WATER PURIFIER (K000941)Sterltech, Inc.2000-04-06
URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A (K000462)Dade Behring, Inc.2000-04-06
JEL 15 (K000532)J.F. Jelenko & Co., Inc.2000-04-06
OSTEONICS SERIES 7000 AD TIBIAL TRAY (K983657)Osteonics Corp.2000-04-06
LEVEEN NEEDLE ELECTRODE (K982556)Radiotherapeutics Corp.2000-04-06
BICON-PLUS ACETABULAR COMPONENTS (K992154)Plus Orthopedics2000-04-06
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT (K000748)Armkel, LLC2000-04-06
PEDIATRIC FIXATION RODS (K000764)Biomet, Inc.2000-04-06
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A (K000461)Dade Behring, Inc.2000-04-06
ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST (K000489)Helix Diagnostics, Inc.2000-04-05
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE (K000330)Siam Sempermed Corp., Ltd.2000-04-05
SKYLIGHT IMAGING SYSTEM (K000908)Adac Laboratories2000-04-05
FLEXTIME (K000629)Heraeus Kulzer, Inc.2000-04-05
URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A (K000466)Dade Behring, Inc.2000-04-05
RANDOX CALCIUM (K000375)Randox Laboratories, Ltd.2000-04-05
HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) (K000725)Hwa Teh Industrial Sdn. Bhd.2000-04-05
ARCHITECH AFP MASTERCHECK, MODEL 6C01-05 (K992781)Bio-Rad2000-04-05
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K000872)Shanghai Antares Industries, Inc.2000-04-05
LUXAFORM (K000951)Dmg USA, Inc.2000-04-05
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE (K000329)Siam Sempermed Corp., Ltd.2000-04-05
INSYTE CATHETER, INSYTE AUTOGUARD CATHETER (K000235)Becton Dickinson Infusion Therapy Systems, Inc.2000-04-05
DIMENSION PENTA L (K000595)Espe Dental AG2000-04-05
NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE (K000323)Siam Sempermed Corp., Ltd.2000-04-05
COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II (K000534)Roche Diagnostics Corp.2000-04-05
ACTICOAT FOAM DRESSING (K000051)Westaim Biomedical, Inc.2000-04-05
PROVEN KNEE SYSTEM (K000113)Stelkast Company2000-04-04
MS-ONE, MODEL MS-1 (K994065)Home Wellness West2000-04-04
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS (K000029)Ela Medical, Inc.2000-04-04
SUNI MAX (K000049)Satelec2000-04-04
RENAFLO II HF 2000 HEMOFILTER (K000028)Minntech Corp.2000-04-04
MEDISUL DISPOSABLE VAGINAL SPECULUM (K000414)Marketing Perspectives2000-04-04
BOHN FEMORAL COMPONENT (K000262)Biomet Manufacturing, Inc.2000-04-03
ASNIS III CANNULATED SCREW SYSTEM (K000080)Howmedica Osteonics Corp.2000-04-03
← Previous Next →

Track 2000 automatically

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