Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION) (K914407)Promedex, Inc.1991-12-31
SONICAID TEAM (K912639)Oxford Medilog, Inc.1991-12-31
QUICKSTART UREA NITROGEN (K914903)Em Diagnostic Systems, Inc.1991-12-31
PTI INTRA-ART (TM) PICK-UP WICKS (K905068)Pioneering Technologies, Inc.1991-12-31
OPTI-PLAST 5F PTA CATHETERS, MODIFICATION (K914500)Vas-Cath, Inc.1991-12-31
MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED (K910665)Ge Medical Systems Information Technologies1991-12-31
CORONET 100 (K913785)Micro-Shev , Ltd.1991-12-31
THERASTIM (K914813)Precision Electronics , Ltd.1991-12-31
UNIVERSAL TERMINAL CAP, 3.2MM (K913919)Telectronics Pacing Systems, Inc.1991-12-31
SIRIUS (K912813)Pfizer Laser Systems1991-12-31
SPECTACLE FRAMES (K914413)Mikado Ca.1991-12-31
STOPCOCK (K913560)Graham Medical Products1991-12-31
CHEM-SLEEVE B (K912257)Haz-Med, Inc.1991-12-31
GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST (K914913)Ideal Medical, Inc.1991-12-31
PYRAMID SUNGLASSES/READING GLASSES (K914425)Pyramid1991-12-31
PHONAK 9000-AF ITE HEARING INSTRUMENT SERIES (K915461)Phonak, Inc.1991-12-30
RAPI-JECT(R) SYRINGE (K911440)David Bull Laboratories, USA, Inc.1991-12-30
SYSMEX NE-1500, MODIFICATION (K914744)Toa Medical Electronics USA, Inc.1991-12-30
ELECTROSCOPE MONITOR, EM-1 (K913625)Electroscope, Inc.1991-12-30
ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) (K912740)Visionary Systems, Inc.1991-12-30
AESCULAP SURGICAL ACCESSORIES (K913262)Aesculap, Inc.1991-12-30
FUN FLOSS (K914962)Fun Floss Co.1991-12-30
NPG III CASTING ALLOY (K915247)Aalba Dent, Inc.1991-12-30
PS MEDICAL VENTRICULOSTOMY KIT (K915546)Pudenz-Schulte Medical Research Corp.1991-12-30
IMMUNOWELL LYME (P39 RECOMBINANT) TEST (K911599)General Biometrics, Inc.1991-12-30
TRANSCERVICAL INTRAUTERINE KIT (K914387)Telos Medical Corp.1991-12-30
OSTEO CERCLAGE WIRE (K914374)Osteo AG1991-12-30
S-ROM ZT HA PROXIMAL FEMORAL SLEEVE (K912713)Joint Medical Products Corp.1991-12-30
PERCUDISC(TM) SYSTEM (K910823)Percudisc, Inc.1991-12-30
MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD (K912780)Electroscope, Inc.1991-12-30
FRAMES (SPECTACLES) VARIOUS TYPES (K914614)Match Optical Co.1991-12-30
KELLER CARDIAC MONITOR MEDIL KMS870 (K914576)Keller Medical Specialties Products, Inc.1991-12-30
LPG CASTING ALLOY (K915248)Aalba Dent, Inc.1991-12-30
ELECTROSHIELD (K912781)Electroscope, Inc.1991-12-30
SIMPEX INC. ORAL AND RECTAL THERMOMETERS (K913793)Simpex, Inc.1991-12-30
TEF/PLATINUM PISTON (K915120)River Medical, Inc.1991-12-27
CAVITY VARNISH PRODUCT (K914324)Confi-Dental Products Co.1991-12-27
SERIES 1500 12-LEAD ANALYSIS OPTION (K903644)Marquette Electronics, Inc.1991-12-27
MAGNETOM 42 SP,63 SP,IMPACT (K915112)Siemens Medical Solutions USA, Inc.1991-12-27
XEMEX TEMPORARY PACING CATHETER A MODIFIED (K913521)Zeon Medical Corp.1991-12-27
PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE (K915118)Ipax, Inc.1991-12-27
ELISA RUBELLA IGM (K914420)Sclavo, Inc.1991-12-27
DIGITRAPPER MARK III (K913387)Synectics-Dantec1991-12-27
ANGIOLAZ ANGIOSCOPE CATHETER (K913129)Angiolaz, Inc.1991-12-27
MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES (K913175)G-C Intl. Corp.1991-12-27
OLYMPUS RETRACTABLE VALVULOTOME (K911702)Olympus Corp.1991-12-27
GENESIS UNICOMPARTMENTAL KNEE SYSTEM (K912735)Smith & Nephew Richards, Inc.1991-12-27
STOMA MEASURING DEVICE (K914482)Biosearch Medical Products, Inc.1991-12-27
VORTECH'S IMAGE ARCHIVAL AND RETRIEVAL SYSTEM (K915094)Vortech Data, Inc.1991-12-27
KIRSCHNER(R) HYBRIDFIT TOTAL KNEE SYSTEM (K913492)Kirschner Medical Corp.1991-12-27
PHACO TIP (K914229)Tri-Star Ophthalmic1991-12-27
APEX(TM) PROSTATIC BALLOON DILATION CATHETER (K913477)Peripheral Systems Group1991-12-27
ADVANTAGE V.S. CT/MR RAD DIAGNOSTIC WORKSTATION (K913770)General Electric Co.1991-12-27
MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP (K915353)Matrix Medica, Inc.1991-12-27
SIGMA PROCEDURE NO. 333-UV (K914777)Sigma Diagnostics, Inc.1991-12-27
CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH (K914316)Medi-Flex Hospital Products, Inc.1991-12-24
DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE (K912384)Nidek, Inc.1991-12-24
LIMA 28MM CERAMIC HEAD, MODIFICATION (K912985)Turnkey Intergration USA, Inc.1991-12-24
LULMITEX NEONATAL TRANSILLUMINATOR (K912747)Lumitex, Inc.1991-12-24
PATIENT EXAMINATION GLOVES (K914284)K-International Exports Pvt. , Ltd.1991-12-23
MODEL HD-207 BIDIRECTIONAL VELOCITY METER (K912409)Koven and Assoc., Inc.1991-12-23
ADVANCE(R) PREGNANCY TEST (K914990)Ortho Pharmaceutical Corp.1991-12-23
SURGICAL OBTURATOR WITH SEAL (K911730)Applied Vascular Devices, Inc.1991-12-23
MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS (K914433)Medtronic Vascular1991-12-23
TEF/WIRE PISTON (K915121)River Medical, Inc.1991-12-23
COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE (K912994)Wilde-USA, Inc.1991-12-23
TEFLON COATED ELECTRODES/ELECTRODES HANDLES (K913108)Olsen Electrosurgical, Inc.1991-12-23
SURGI LIGHT NON-CONTACT FIBERS (K914396)Lifestream Int'L, Inc.1991-12-23
ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO) (K912581)Carl Zeiss, Inc.1991-12-23
DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION (K914985)E-Z-Em, Inc.1991-12-20
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT (K911880)Bill Olson Corp.1991-12-20
TURBO (K912854)Kinetic Concepts, Inc.1991-12-20
ALPHA-2 MACROGLOBULIN TEST RID KIT (K914389)The Binding Site, Ltd.1991-12-20
INTERSON ENDOCAVITY PROBE/KONTRON ULTRASOUND SYST (K911116)Interson Corp.1991-12-20
THE BODY BUGGY (K915361)Innova Corp.1991-12-20
MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST (K913358)Ppg Industries, Inc.1991-12-20
VEOLAR VENTILATOR (K901448)Hamilton Medical, Inc.1991-12-20
SERENA WHEELCHAIR CUSHIONS (K915368)A & C Medical Supply1991-12-20
IONTOPHORESIS DEVICE, MODIFICATION (K914621)Iomed, Inc.1991-12-20
HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD) (K915234)Hemagen Diagnostics, Inc.1991-12-20
PHILIPS MAMMODIAGNOST BC (K913845)Philips Medical Systems, Inc.1991-12-20
MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM (K914952)Trimedyne, Inc.1991-12-20
TRANSQ 2 (K914264)Iomed, Inc.1991-12-20
S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD (K913231)Joint Medical Products Corp.1991-12-20
SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE (K912418)Micromedics, Inc.1991-12-20
CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT (K913668)The Binding Site, Ltd.1991-12-20
SOS BLOODLESS NEEDLE (K914330)E-Z-Em, Inc.1991-12-20
HEMAGEN ENA SCREENING KIT (EIA METHOD) (K915058)Hemagen Diagnostics, Inc.1991-12-20
IMMUNOWELL BORRELIA (LYME)TEST (K911590)General Biometrics, Inc.1991-12-20
SPORTS HEAT WRAP (K915241)Conair Corp.1991-12-20
CONTEMPRO2 HOME HEALTH CARE REGULATOR (K913327)Continental Products, Inc.1991-12-20
PT II DISTAL CEMENT SPACER (K914406)Osteonics Corp.1991-12-20
CATHETER, URETERAL DILATOR (K914617)Boston Scientific Corp1991-12-20
CARDIOVASCULAR REPAIR PATCH (K905073)Impra, Inc.1991-12-20
PREALBUMIN IMMUNOLOGICAL NL TEST KIT (K913672)The Binding Site, Ltd.1991-12-20
CUSTOM TUBING PACKS (K913363)Kroy Medical, Inc.1991-12-20
OPTIMA (K913222)Olympic Controls Corp.1991-12-20
TOUCH N TONE 1 MASSAGER (K915242)Conair Corp.1991-12-20
BIOMET MODULAR TOTAL HIP FEMORAL COMPONENTS (K912712)Biomet, Inc.1991-12-20
MOLAR DISTALIZING ASSEMBLY (K912417)American Orthodontics1991-12-20
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Track 1991 automatically

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