Atlas FDA

1995

5,487 FDA 510(k) clearances · Clearance year

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RecordFirmDate
HYBRID SURGICAL DEVICES, MODIFICIATION (K951353)Laser Centers of America, Inc.1995-04-06
WELCH ALLYN OTOSCOPE (K950787)Welch Allyn, Inc.1995-04-06
CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY (K945521)Menlo Care, Inc.1995-04-06
FI-10M (K951194)Pentax Precision Instrument Corp.1995-04-06
TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER (K934975)Rlt Medical Assoc., Inc.1995-04-06
ENDOBOOT (K951104)United States Endoscopy Group, Inc.1995-04-06
CATCO SILICONE UMBILICAL VESSEL CATHETER (K944368)Catco Medical, Inc.1995-04-05
PREMIER PROMAX BITE GUARD (K941856)Premier Dental Products Co.1995-04-05
URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE (K950136)E.I. Dupont DE Nemours & Co., Inc.1995-04-05
PYLORISET DRY (K942974)Orion Diagnostica, Div. Orion Corp.1995-04-05
CATCO POLYURETHANE UMBILICAL VESSEL CATHETER (K944367)Catco Medical, Inc.1995-04-05
OLYMPUS PBD STENTS (K933200)Olympus Corp.1995-04-05
MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM (K944614)Biosearch Medical Products, Inc.1995-04-05
IRISPEC URINE CHEMISTRY CONTROL PART A AND B (K945913)International Remote Imaging Systems1995-04-05
HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES (K936056)Dipro Diagnostic Products GmbH1995-04-05
ROCHE ABUSCREEN ONLINE FOR METHAQUALONE (K945187)Roche Diagnostic Systems, Inc.1995-04-05
PERSYST SPIKE DETECTOR (K950117)Persyst Consulting Services, Inc.1995-04-05
AVL OMNI ANALYZER (K945915)Avl Scientific Corp.1995-04-05
SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER (K950047)Isomedix Operations, Inc.1995-04-05
MEDTRONIC(R) 8.2 FRENCH SHERPA(R) SUPER PEAK FLOW(TM) CORONARY GUIDING CATHETER (K950026)Medtronics Interventional Vascular1995-04-05
SCIMED 6 FRENCH EXPO ANGIOGRAPHIC CATHETER (K950731)Scimed Life Systems, Inc.1995-04-05
AVON MASSAGING HAIRBRUSH (K950931)Siegel,Mandell & Davidson,P.C.1995-04-05
CATCO UMBILICAL VESSEL CATHETER (K944336)Catco Medical, Inc.1995-04-05
URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE (K950181)E.I. Dupont DE Nemours & Co., Inc.1995-04-05
ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE (K950156)Advanced Cardiovascular Systems, Inc.1995-04-05
DV TEST AND DVV CONFIRM (K940490)American Diagnostica, Inc.1995-04-05
OCTEIA IGF-1 KIT (K950510)Immunodiagnostic Systems , Ltd.1995-04-05
NOVATRANS II (K951129)Medex, Inc.1995-04-05
PROVIDENT HP SYSTEM (K946371)Stelkast Company1995-04-05
CONSENSUS(TM) PATELLA REAMER (K946197)U.S. Medical Products, Inc.1995-04-05
CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETER (K944410)Catco Medical, Inc.1995-04-05
ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR) (K950904)Orthofab, Inc.1995-04-05
ORTHOFAB WHEELCHAIR ULTIMA (RIGID FRAME MANUAL WHEELCHAIR) (K950903)Orthofab, Inc.1995-04-05
CHEMILUMINESCENCE LH (K935319)Nichols Institute Diagnostics1995-04-05
KARL STORZ MODIFIED VERESS NEEDLE AND CANNULA (K950282)KARL STORZ Endoscopy-America, Inc.1995-04-05
PINWORM EGG COLLECTOR (K950096)Evergreen Industries, Inc.1995-04-05
GALAXY MD SERIES THERAPYPOOLS (K945824)Galaxy Aquatics, Inc.1995-04-05
POLYDERM (K950033)Wilshire Technologies1995-04-04
LE CLEAN MACHINE (K950240)Parkell, Inc.1995-04-04
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS (K945911)Bioclinical Systems, Inc.1995-04-04
BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER (K942250)Biowhittaker Molecular Applications, Inc.1995-04-04
TURBO 25/30 (K950256)Parkell, Inc.1995-04-04
AUTOLASER MULTI FORMAT CAMERA (K950288)Afp Imaging Corp.1995-04-04
ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM (K944092)Orthofix Srl1995-04-04
SUNGLASSES (K951209)Mainland Wholesale1995-04-04
WELCH ALLYN OPHTHALMOSCOPE (K950461)Welch Allyn, Inc.1995-04-04
B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE (K950982)B. Braun of America, Inc.1995-04-04
RAINS FRONTAL SINUS STENT (K951066)Smith & Nephew Richards, Inc.1995-04-04
WHITSOFT (K942361)Biowhittaker Molecular Applications, Inc.1995-04-04
CARRYALL ENHANCEMENTS (K943931)Instromedix, Inc.1995-04-04
SMOKIEVAC ELECTROSURGICAL PENCIL (K946104)Aspen Laboratories, Inc.1995-04-03
CURASORB ZN ALGINATE WOUND DRESSING (K950775)Kendall Healthcare Products Co. Div.Of Tyco Health1995-04-03
KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE (K951251)KARL STORZ Endoscopy-America, Inc.1995-04-03
AURAFLEX(R) ESTRADIOL (K946199)Organon Teknika Corp.1995-04-03
SKYTRON SKYBOOM SERIES (K950192)Skytron, Div. the Kmw Group, Inc.1995-04-03
M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM (K944309)M.E.R. Surgical Co.1995-04-03
POLYDOROS SX 65 AND 80 (K950883)Siemens Medical Solutions USA, Inc.1995-04-03
IMMULITE(R) TBG (K950072)Diagnostic Products Corp.1995-04-03
GRX FOAM DRESSING (K945224)Geritrex Corp.1995-04-03
KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7) (K951006)Kenex , Ltd.1995-04-03
ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 (K950981)Biodex Medical Systems, Inc.1995-04-03
KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) (K951003)Kenex , Ltd.1995-04-03
THERMOLASE LT-100 ND:YAG LASER HAIR REMOVAL SYSTEM; THERMOLASE LT-100;LT-100 (K950019)Thermolase Corp.1995-04-03
BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY (K945962)Bennett X-Ray Corp.1995-04-03
BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE (K942245)Biowhittaker Molecular Applications, Inc.1995-04-03
ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X (K926364)3M Health Care, Ltd.1995-03-31
ATTENUATION CORRECTION (K945652)GE Medical Systems1995-03-31
CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE (K950254)Cypress Medical Products, Ltd.1995-03-31
MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM (K941353)Elscint, Inc.1995-03-31
SILVER ULTRA MINI CANAL (K950458)Electone, Inc.1995-03-31
R-MED DISPOSABLE PLUG (K942411)R-Med, Inc.1995-03-31
MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AID (K950691)Miracle-Ear, Inc.1995-03-31
MIRACLE-EAR MODEL PBS PROGRAMMABLE HEARING AID (K950692)Miracle-Ear, Inc.1995-03-31
COMPACT-X (K950694)Electromed Intl., Ltd.1995-03-31
M-PATH NITINOL GUIDEWIRE (K946356)Microvena Corp.1995-03-31
SCIMED(R) CHOICE(TM) PTCA GUIDE WIRE (K950141)Scimed Life Systems, Inc.1995-03-31
MICRO RSH HIGH SPEED HANDPIECE (K935676)Micro Motors, Inc.1995-03-31
CORSINI 9090 (K950402)C.A.T. DI Corsini G. & C. Spa1995-03-31
UNITRON MODEL ESTEEM (K950759)Unitron Industries, Inc.1995-03-31
CATCO FIRST PICC (K944504)Catco Medical, Inc.1995-03-31
ORAL PROCEDURE PACK (K950743)Transidyne General Corp.1995-03-31
UNIVERSAL URETHRAL CATHETER (K946282)Louisville Laboratories, Inc.1995-03-31
SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS) (K950894)Argen Precious Metals, Inc.1995-03-31
INFRARED EXPOSURE HAND SWITCH (K950442)Medical X-Ray Intl., Inc.1995-03-31
NTBS-1417, 1436, TBS-1417 (K946260)Scott Imaging Intl., Inc.1995-03-31
REUSABLE TROCAR WITH SAFETY SLEEVE (K950021)L.A.S.E.R., Inc.1995-03-31
KARL STORZ STENT APPLICATOR FORCEPS (K950965)KARL STORZ Endoscopy-America, Inc.1995-03-31
TRIFLEX NON-STERILE SYNTHITIC EXAMINATION GLOVES (K944873)Baxter Healthcare Corp1995-03-31
LASER GAS MIXTURE (K951045)Liquid Carbonic Industrial Gases1995-03-31
SCIMED(R) CHICE(TM) EXCHANGE PTCA GUIDE WIRE (K950113)Scimed Life Systems, Inc.1995-03-31
LORAD M-IV, LORAD M-IVI (K945241)Lorad Corp.1995-03-31
RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM) (K951111)Lifecore Biomedical, Inc.1995-03-31
PREFERENCE MAMMOGRAPHY SYSTEM (K945743)Philips Medical Systems (Cleveland), Inc.1995-03-31
MIRACLE-EAR MODEL PM1/PM2 PROGRAMMABLE HEARING AID (K950693)Miracle-Ear, Inc.1995-03-31
SIMVIEW(TM) 3000 (K946053)Siemens Medical Solutions USA, Inc.1995-03-31
PROPHYLAXIS PACK (K950773)Transidyne General Corp.1995-03-31
LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 (K950571)Continental X-Ray Corp.1995-03-31
BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT (K944844)Baxter Healthcare Corp1995-03-31
CATO FIRST PICC-DUAL LUMEN (K944685)Catco Medical, Inc.1995-03-31
C-POST (K945370)Bisco, Inc.1995-03-31
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Track 1995 automatically

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