Atlas FDA

1995

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

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RecordFirmDate
KAPLAN-SIMPSON INFUSASLEEVE CATHETER (K950615)Localmed, Inc.1995-04-19
MEDI - PUMP (K950867)Thomas Industries1995-04-19
TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY (K950532)Trophy Radiologie1995-04-19
TIP DEFLECTOR (GENESIS) (K943257)Electro-Catheter Corp.1995-04-19
BARNARD & ASSOCIATES REMANUFACTURED GENERAL PURPOSE, VACUUM OR LABORATORY STERILIZER (K950341)Barnard and Assoc.1995-04-19
CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP (K941743)Cabot Medical Corp.1995-04-19
TECOTHANE 55D (K950425)Medtronic Vascular1995-04-19
UPSCAN (K933512)Merlin Engineering Works, Inc.1995-04-19
CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION (K933450)Electro-Catheter Corp.1995-04-19
HOLTER FOR WINDOWS (K930564)North East Monitoring, Inc.1995-04-19
STAND, INFUSION (K946201)Medical Specialties, Inc.1995-04-18
THE AQUA-AIR PROFESSIONAL FIELD UNIT(S) (K950175)Aqua-Air Medical Devices, Inc.1995-04-18
ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS (K950301)Becton Dickinson Vascular Access, Inc.1995-04-18
DIGENE DCR-1 LUMINOMETER (K940486)Digene Diagnostics, Inc.1995-04-18
HPRH HOSPITAL PATIENT RADIANT HEATER (K934262)Marley Electric Heating Co.1995-04-18
INFINITECH ASPIRATING LASER PROBE (K946135)Surgical Technologies, Inc.1995-04-18
TSI WILLEN-REICH NEEDLE (K950726)Tahoe Surgical Instruments P.R., Inc.1995-04-18
HARMONY LINE KF (K951297)Ivoclar North America, Inc.1995-04-18
FRINDLEY ENTERPRISE CO (K942142)Frindley Enterprise Co., Ltd.1995-04-18
MAXIGOLD KF (K951298)Ivoclar North America, Inc.1995-04-18
STERIGAGE EO 100% (K934874)Pymah Corp.1995-04-18
NONE-GENERIC (K940725)Yon'S Jay Enterprise Co.1995-04-18
DERMAGRAN HYDROPHILIC OINTMENT (K951499)Derma Sciences, Inc.1995-04-18
DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM (K951301)Depuy, Inc.1995-04-18
WOUND CLOSURE/LACERATION TRAY (K950295)Customed, Inc.1995-04-18
SUNGLASSES (K951439)Long Train Enterprise Co., Ltd.1995-04-18
PRO-LOCK (K951236)Health-Dent Intl., Inc.1995-04-18
BEHRING FIBRINTIMER A (K926551)Behring Diagnostics, Inc.1995-04-18
LASERSONICS ULTRALINE III STERILE DISPOSABLE FIBER (K951215)Heraeus Surgical, Inc.1995-04-18
PROFORM POROUS ACETABULAR ASSEMBLY (K950827)Stelkast Company1995-04-18
BIPOLAR SNARE (K950776)Cook Urological, Inc.1995-04-18
ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT (K951423)Impact Instrumentation, Inc.1995-04-18
SLT SIDEFIRING REFRACTIVE FIBER (HIGH POWER DENSITY FIBER) (K950819)Surgical Laser Technologies, Inc.1995-04-18
VARELISA ANA PROFILE (K951205)Elias U.S.A., Inc.1995-04-17
INTRAARC DRIVE SYSTEM (K951263)Linvatec Corp.1995-04-17
VARELISA PARIETAL CELL ANTIBODIES (K951206)Elias U.S.A., Inc.1995-04-17
AUTOSTAT II ANTI-TPO (K943580)Cogent Diagnotics , Ltd.1995-04-17
ULTRACELL ORTHOPEDIC SPONGES (K950372)Ultracell Medical Technologies, Inc.1995-04-17
VARELISA COMBINED DNA ANTIBODIES EIA (K944334)Elias U.S.A., Inc.1995-04-17
ULTRACELL ORTHOPEDIC SPONGES (K950370)Ultracell Medical Technologies, Inc.1995-04-17
OXYLATOR EM-100 (K944349)Cpr Medical Devices, Inc.1995-04-17
SPECULUM, ENT (S3) (K951050)Pedia Pals, Inc.1995-04-17
ULTRACELL ORTHOPEDIC SPONGES (K950373)Ultracell Medical Technologies, Inc.1995-04-17
OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT (K951055)Olympus America, Inc.1995-04-17
LOCKETT MEDICAL CORP. GAUZE (K950404)Lockett Medical Corp.1995-04-17
SPECULUM, ENT (S3) (K951049)Pedia Pals, Inc.1995-04-17
VARELISA ANA-4 SCREEN (K951186)Elias U.S.A., Inc.1995-04-17
OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT (K951013)Olympus America, Inc.1995-04-17
N/T PROTEIN CONTROL PY (K951012)Behring Diagnostics, Inc.1995-04-17
SCIMED(R) COURIER GUIDE CATHETER (K946272)Scimed Peripheral Interventions1995-04-17
RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS) (K951560)Radius Intl., Inc.1995-04-17
VARELISA HISTONE ANTIBODIES (K951207)Elias U.S.A., Inc.1995-04-17
SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM (K943883)Aladan Corp.1995-04-14
DRIED GRAM-NEGATIVE MIC//COMBO PANELS (K935704)Baxter Diagnostics, Inc.1995-04-14
DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING (K951345)Catheter Research, Inc.1995-04-14
MICOS MICROPULSE(TM) ALTERNATING PRESSURE MATTRESS (K945629)Micos Medical Systems1995-04-14
VARIANT TOTAL GHB PROGRAM (K941616)Bio-Rad1995-04-14
PREMIER EHEC (K950167)Meridian Diagnostics, Inc.1995-04-14
ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM (K951000)Joint Medical Products Corp.1995-04-14
MULTIPLE (IZON DBS & URINE COLLECTION KIT) (K950257)Izon Business Products, Inc.1995-04-14
SCIMED(R) CHOICE(TM) PT EXCHANGE PTCA GUIDE WIRE (K950266)Scimed Life Systems, Inc.1995-04-14
CORDIS STEERABLE GUIDEWIRES (K950316)Cordis Corp.1995-04-14
CARD GUARD (K934795)Card Guard Scientific Survival , Ltd.1995-04-14
AMOXICILLIN/CLAVULANIC ACID 2/1 (K950328)Ab Biodisk North America, Inc.1995-04-14
CO2 INSUFFLATOR 1100 (K930013)Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz1995-04-14
NITE-GUIDE (K931615)ORTHO-TAIN, Inc.1995-04-14
SPETZLER PIN (K945639)Howmedica Corp.1995-04-14
RESOUND PERSONAL HEARING SYSTEM BT2/S SERIES W/REMOTE CONTROL OPTION (K951376)Resound Corp.1995-04-14
STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA (K950308)Solarcare Technologies Corp,Inc.1995-04-14
ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS (K941709)Acufex Microsurgical, Inc.1995-04-14
RESOUND PERSONAL HEARING SYSTEM BTP/S-A W/REMOTE CONTROL OPTION (K951377)Resound Corp.1995-04-14
PORTA-SCREEN SPIROMETER (K951367)S & M Instrument Co.1995-04-14
SURESHARP (K950159)Gainor Medical U.S.A., Inc.1995-04-14
GAUZE, NONABSORABLE, NON-MEDICATED (INTERNAL SPONGE) (K950462)Spring Intl., Inc.1995-04-14
RESOUND PERSONAL HEARING SYSTEM ED3/S-E (K951375)Resound Corp.1995-04-14
STERI-OSS SCALER FOR DENTAL IMPLANTS (K943681)Steri-Oss, Inc.1995-04-14
SYSTEM 22 VALVE (K950397)Turnkey Intergration USA, Inc.1995-04-14
OXYGEN REGULATOR (K950777)Mada Medical Products, Inc.1995-04-14
LEUR TIP CAP, VLT CAP(TM) (K945454)Martell Medical Products, Inc.1995-04-14
LORREX GAUZE PADS (1'S) AND LORREX GAUZE SPONGES - STERILE 2'S AND STERILE 10'S AND NON-STERILE (K951418)Lorons International Corp.1995-04-14
ARTHREX CANCELLOUS SCREW AND WASHER (K945426)Arthrex, Inc.1995-04-14
GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300 (K940009)General Devices1995-04-14
RESOUND PERSONAL HEARING SYSTEM BT2/S-E (K951374)Resound Corp.1995-04-14
ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN (K950677)Atrium Medical Corp.1995-04-13
MESH MATRIX WOUND DRESSING (K950281)Brennen Medical, Inc.1995-04-13
PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR (K950164)Abaxis, Inc.1995-04-13
IMPLANTABLE CLIP (K950540)United States Surgical, A Division of Tyco Healthc1995-04-13
TACTYLON(TM) POWDER FREE SURGEONS GLOVE (K950185)Tactyl Technologies, Inc.1995-04-13
BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE (K945398)Nobelpharma USA, Inc.1995-04-13
A2 DETACHED DUAL PORT SYSTEM (K950212)Therex Corp.1995-04-13
SPINAL MARKER (K944188)Leibinger L.P.1995-04-13
CLINICAL VOICE THERMOMETER (K935466)Blazie Engineering, Inc.1995-04-13
COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC) (K951137)Wembley Rubber Products (M) Sdn Bhd1995-04-13
ELSA-PTH (K950211)Cis-Us, Inc.1995-04-13
BELTONE COMPARAFIT (K946340)Beltone Electronics Corp.1995-04-13
ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP (K945610)Princeton BioMeditech Corp.1995-04-13
ULTRACELL RETRACTOR COVERS (K950659)Ultracell Medical Technologies, Inc.1995-04-13
BONE PLATE SYSTEM (K942359)Acu Med, Inc.1995-04-13
IMEDGE VIDEO OSTOSCOPE (ANALOG) (K951255)Introspect, Inc.1995-04-13
SCIPOTEX (K951171)Wembley Rubber Products (M) Sdn Bhd1995-04-13
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Track 1995 automatically

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