Atlas FDA

1995

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

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RecordFirmDate
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY (K951321)Bio-Rad1995-08-24
FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 (K946265)Clinical Controls, Inc.1995-08-24
ADVANTAGE TEST STRIPS (K951887)Boehringer Mannheim Corp.1995-08-24
BIOBOX WITH FUNNEL TOP (SMALL, MEDIUM, LARGE, AND X-LARGE) (K950898)Biosystems1995-08-24
MEDI - PUMP (K950290)Thomas Industries1995-08-24
FLOLAB (K951442)Synectics Medical, Inc.1995-08-24
FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 (K946193)More Diagnostics1995-08-24
QUEST VEIN GRAFT PERFUSION SET (K952531)Quest Medical, Inc.1995-08-24
ULTRA-BLEND (K953524)Ultradent Products, Inc.1995-08-24
ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM (K950255)Argus Medical Co., Inc.1995-08-24
VZV IGG ELISA TEST (K941046)Gull Laboratories, Inc.1995-08-24
OPUS T4 CONTROLS (K953097)Behring Diagnostics, Inc.1995-08-24
ALKPHASE-B ASSAY KIT (K952768)Metra Biosystems, Inc.1995-08-24
AQUISEN (K952583)Aquintel, Inc.1995-08-24
HI-LINE MEDICAL PHACOEMULSIFIER TIP (K952468)Hi-Line Medical1995-08-24
BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY (K952839)Boehringer Mannheim Corp.1995-08-24
SPLASH ASSIST (K952303)Innovative Outsourcing Solutions1995-08-24
AXSYM ACETAMINOPHEN (K953094)Abbott Laboratories1995-08-24
AXSYM THEOPHYLLINE II (K953016)Abbott Laboratories1995-08-24
VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES (K950153)Imed Corp.1995-08-24
HUMAN C5 RID KITS (K942326)Jay H. Geller1995-08-24
BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE) (K950897)Biosystems1995-08-24
SONICAID MODEL TEAM FECG IUP (K930714)Oxford Instruments, Plc.1995-08-24
VL7600 REM PATIENT RETURN ELECTRODE (K953737)Valleylab, Inc.1995-08-23
BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFT (K950598)Bio-Interfaces, Inc.1995-08-23
MAGNETOM VISION (PROJECT 016) (K945779)Siemens Medical Solutions USA, Inc.1995-08-23
EBV LGG ELISA TEST (K941198)Gull Laboratories, Inc.1995-08-23
PHONAK PICONET 232X-AZ HEARING INSTRUMENT (K945439)Phonak, Inc.1995-08-23
INFANT HEEL WARMER (K950680)Baxter Healthcare Corp1995-08-23
SIENET DICOM GATEWAY (K952533)Siemens AG1995-08-23
CO2 ARTHROFLATOR (K953550)KARL STORZ Endoscopy-America, Inc.1995-08-23
KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL (K950337)KARL STORZ Endoscopy-America, Inc.1995-08-23
SPECTACLE SUNGLASSES(NON-PRESCRIPTION) (K953629)Lowinger Holdings, Inc.1995-08-23
IP500 NUCLEAR GAMMA CAMERA SYSTEM (K952109)Siemens Medical Solutions USA, Inc.1995-08-23
ACUFEX TAG ANCHOR (K953459)Acufex Microsurgical, Inc.1995-08-23
CONCEIVE OVULATION PREDICTOR (K953063)Quidel Corp.1995-08-23
UIMAT PUMP (K953132)KARL STORZ Endoscopy-America, Inc.1995-08-23
AQUAFLO HYDROGEL WOUND DRESSING & PACKER (K952945)Sherwood Medical Co.1995-08-23
RAPID-FOAM (K952457)The Soule Co., Inc.1995-08-23
MODEL 445SI-64 & 445SI-42A: QUARDRATURE WRIST COIL (K952944)Medical Advances, Inc.1995-08-23
3M MODEL 8200P MULTIPRO BTE (K953543)3M Company1995-08-23
OPUS B12 (K953455)Behring Diagnostics, Inc.1995-08-23
DMA TOTAL CHOLESTEROL PROCEDURE (K946161)Data Medical Associates, Inc.1995-08-23
ULTRASOUND SCANNER 2001 (K936024)B & K Medical A/S1995-08-22
TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP (K950057)Becton Dickinson Immunocytometry Systems1995-08-22
COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE (K924408)Colla-Tec, Inc.1995-08-22
Z20 (K953047)Electone, Inc.1995-08-22
ZEIMER SELF TONOMETER (K953031)Cds Technologies1995-08-22
BIO-LOGIC AUTOMATIC EVENT ANALYSIS (K951594)Bio-Logic Systems Corp.1995-08-22
Z33 (K953050)Electone, Inc.1995-08-22
HYDROGUM (K935898)Zhermack Dental Production1995-08-22
GENESIS II TOTAL KNEE SYSTEM (K951987)Smith & Nephew Richards, Inc.1995-08-22
USSC POLYSORB SUTURE (K951520)United States Surgical, A Division of Tyco Healthc1995-08-21
TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET (K953289)Davis & Geck, Inc.1995-08-21
PLAYTEX TAMPONS #13695 (K952394)Playtime Products, Inc.1995-08-21
CORSSFIRE PLUS (K953658)Cardiogenes1995-08-21
SPYROFLEX WOUND DRESSING (K953618)Polymedica Industries, Inc.1995-08-21
SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM (K951626)Synthes (Usa)1995-08-21
OGDEN ANCHOR (K952348)American Medical Electronics, Inc.1995-08-21
DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN (K952270)Sorin Biomedical, Inc.1995-08-21
KSEA EXTRACTION BAG (K953549)KARL STORZ Endoscopy-America, Inc.1995-08-21
POLYETHYLENE TEREPHTHALATE (PET) PLEDGET (K953425)Davis & Geck, Inc.1995-08-21
USSC MONOFILAMENT POLYSORB SUTURE (K945285)United States Surgical, A Division of Tyco Healthc1995-08-21
EXCALIBUR PLUS ELECTROSURGICAL UNIT (K953007)Aspen Laboratories, Inc.1995-08-21
VALLEYLAB FORCE 300 (K953195)Valleylab, Inc.1995-08-21
MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL (K952677)Porex Surgical, Inc.1995-08-21
HIP FRACTURE STEM FENESTRATION PLUG (K953067)Howmedica Corp.1995-08-21
MEDI - PUMP (K951729)Thomas Industries1995-08-21
SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM) (K951794)Synthes (Usa)1995-08-21
TRANSIT INFUSION CATHETER (K952874)Cordis Neurovascular, Inc.1995-08-21
SALIVA SAMPLER (K942435)Saliva Diagnostic Systems, Inc.1995-08-21
VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S), SPINE PLATE(S), WASHER(S) & NUT(S) (K951657)Acromed Corp.1995-08-21
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM & WCE DIFFUSER FLAT PROBE DF 2 (K952216)Surgical Laser Technologies, Inc.1995-08-18
FINESSE GUIDEWIRE CORONARY (K952430)Flexmedics1995-08-18
DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES (K950012)International Regulatory Consultants1995-08-18
R&D BATTERIES, INC. PART NUMBERS 5158, 5168, 5171 AND 5172 (K951285)R & D Batteries, Inc.1995-08-18
R&D BATTERIES, INC. PART NUMBERS 5412, 5420, 5436 AND 5438 (K951276)R & D Batteries, Inc.1995-08-18
PERMADYNE GARANT 2:1 (K953374)Espe GmbH & Co. Kg.1995-08-18
R&D BATTERIES PART NOS. 5096, 5115, 5128 AND 5131 (K951404)R & D Batteries, Inc.1995-08-18
R&D BATTERIES PART NOS. 5064, 5157, 5489 AND 5536 (K951400)R & D Batteries, Inc.1995-08-18
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER (K952887)Meadox Medicals, Div. Boston Scientific Corp.1995-08-18
R&D BATTERIES, INC. PART NUMBERS 5075-B, 5076, 5122 AND 5123 (K951283)R & D Batteries, Inc.1995-08-18
R&D BATTERIES, INC. PART NUMBERS 5039, 5052, 5056 AND 5061 (K951282)R & D Batteries, Inc.1995-08-18
R&D BATTERIS, INC. PART NUMBER 5024, 5027, 5033 AND 5035 (K951281)R & D Batteries, Inc.1995-08-18
SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW (K952296)Synthes (Usa)1995-08-18
POWERGRIP(TM) COMPRESSION FIXATION DEVICE (K950009)Synvasive Technology, Inc.1995-08-18
FOGARTY-HYDRAGRIP SURGICAL CLAMPS (K951413)Baxter Healthcare Corp1995-08-18
R&D BATTEERIES, INC. PART NUMBERS 5173, 5178, 5197 AND 5199 (K951279)R & D Batteries, Inc.1995-08-18
R&D BATTERIES, INC. PART NUMBERS 5213, 5222, 5268 AND 5284 (K951278)R & D Batteries, Inc.1995-08-18
R&D BATTERIES PART NOS. 5015, 5016, 5037 AND 5051 (K951401)R & D Batteries, Inc.1995-08-18
RAMITEC PENTA (K952693)Espe GmbH & Co. Kg.1995-08-18
HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE (K953232)Hollister, Inc.1995-08-18
R&D BATTERIES, INC. PART NUMBERS 5003, 5006, 5008 AND 5012 (K951280)R & D Batteries, Inc.1995-08-18
R&D BATTERIES PART NOS. 5167, 5221, 5244 AND 5247 (K951402)R & D Batteries, Inc.1995-08-18
FIXED FLOW RATE GRAVITY ADMINISTRATION SETS (K952760)I-Flow Corp.1995-08-18
THERMOCOOL SYSTEM (K950395)Zimmer, Inc.1995-08-18
R&D BATTERIES PART NOS. 5164, 5252, 5634 AND 5650 (K951403)R & D Batteries, Inc.1995-08-18
TLC SURGICAL GOWNS (K951623)Tlc Tech Lab Clothes, Inc.1995-08-18
HYPEX(TM) JET INJECTOR (K945873)Equidyne Systems, Inc.1995-08-18
R&D BATTERIES, INC. PART NUMBERS 5453, 5474, 5513 AND 5595 (K951275)R & D Batteries, Inc.1995-08-18
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Every clearance here is in the API, with alerts when new ones post.