Atlas FDA

1977

2,114 FDA 510(k) clearances · Clearance year

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RecordFirmDate
FSH RIA KIT (125I) (K772188)Diagnostic Products Corp.1977-12-22
LDH ISOENZYME CONTROL (K771894)Bio-Reagents & Diagnostics, Inc.1977-12-22
X-RAY SYSTEM FOR DENTAL APPLICATION (K772184)General Electric Co.1977-12-22
ALKALINE PHOSPHATASE TEST SET (K772257)Stanbio Laboratory1977-12-22
IMMUNOGLOBULIN A NEPHEL. ASSAY (K772251)Kallestad Laboratories, Inc.1977-12-22
IMMUNOGLOBULIN M NEPHEL. ASSAY (K772254)Kallestad Laboratories, Inc.1977-12-22
TEMP. ACRYLIC (K772211)Lactong Corp.1977-12-22
SPINSEP-T3 (K771854)Nuclear Diagnostics, Inc.1977-12-22
EMIT CENTRIFICHEM THYROXINE ASSAY (K772170)Syva Co.1977-12-22
TOXO TEST (K772243)Gull Laboratories, Inc.1977-12-22
HAPTOGLOBIN NEPHELOMETRIC ASSAY (K772245)Kallestad Laboratories, Inc.1977-12-22
PCO 2 ELECTROLYTE (K772307)Fisher Scientific Co., LLC1977-12-22
UNCONJUGATED ESTRIOL RIA KIT (K772215)Amersham Corp.1977-12-22
NEBULIZER SET-2C7105 (K772222)Travenol Laboratories, S.A.1977-12-22
DISP. TEFLON CONNHCTOR (K771429)Quinton, Inc.1977-12-22
ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY (K772250)Kallestad Laboratories, Inc.1977-12-22
COMPLEMENT C3 NEPHELOMETRIC ASSAY (K772249)Kallestad Laboratories, Inc.1977-12-22
125I DIGOXIN TEST SET (K772306)Wien Laboratories, Inc.1977-12-22
ALBUMIN NEPHELOMETRIC ASSAY (K772248)Kallestad Laboratories, Inc.1977-12-22
ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY (K772246)Kallestad Laboratories, Inc.1977-12-22
RECEPTAL ATS TRAUMA KGA1900L (K772196)Sorensen Research1977-12-22
IMMUNOGLOBULIN G NEPHEL. ASSAY (K772252)Kallestad Laboratories, Inc.1977-12-22
TRI-TAB-RIA (K772177)Nuclear Medical Laboratories, Inc.1977-12-22
TRANSFERRIN NEPHELOMETRIC ASSAY (K772253)Kallestad Laboratories, Inc.1977-12-22
COMPLEMENT C4 NEPHELOMETRIC ASSAY (K772247)Kallestad Laboratories, Inc.1977-12-22
SCANNER, CT, 0400 (K772289)Pfizer Medical Systems, Inc.1977-12-21
DIAG. CONSOLE, INDEPENDENT (K772291)Pfizer, Inc.1977-12-21
TRANSPARENT MANIFOLD (K772299)Uni-Research1977-12-21
THERMOMETER RECAL ADAPTER (K772233)Info-Chem1977-12-20
DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS (K772098)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-12-20
LAPAROSCOPY DRAPE, BOUNDARY (K772301)Procter & Gamble Mfg. Co.1977-12-20
DEMI-WALKER (REGULAR) (K772268)Med Fusion Systems, Inc.1977-12-20
DUAL WAVELENGTH PHOTOMETER, 1177 (K771909)Abbott Laboratories1977-12-20
QUADRAPLEGIC WALKING AID (K772267)Med Fusion Systems, Inc.1977-12-20
CATH KIT, SUPERPUBIC (K772227)American Hospital Supply Corp.1977-12-20
THYROID BINDING GLOBULIN (K772183)Corning Medical & Scientific1977-12-20
FORCEPS, SUTURE, AUTO (K772286)Hartmann Group, Inc.1977-12-20
CULTURE COLLEC. TRANS. SYS., DOUBLE DRY (K772209)Precision Dynamics Corp.1977-12-20
PROPHYLACTIC (K772181)Om Industries, Inc.1977-12-20
TOTAL HIP, CHARNELY TYPE (K772120)Depuy, Inc.1977-12-20
CYSTIC FIBROSIS TESTING INSTRUMENT (K772176)Laboratory Equipment Design Co.1977-12-20
HEARING AID, BODY TYPE, MODEL H (K772201)Maico Hearing Instruments, Inc.1977-12-20
T-TUBE WHELAN-MOSS (K772292)Davol, Inc.1977-12-20
SWAN GANZ (K771043)Clincal Instruments Corp.1977-12-20
PEDIATRIC INFUSION T (K771426)Quinton, Inc.1977-12-20
PULLEN PLASTIC-PORE PLUGS (K772066)Richard'S Medical Equip., Inc.1977-12-20
PROTECT IV GARD (K772060)Omnicon Medical Corp.1977-12-20
LAPAROSCOPY CONSOLE MODEL VIII (K772242)Kli1977-12-20
EMIT ANTIEPILEPTIC DRUG ASSAYS (K772179)Syva Co.1977-12-20
PERITONEAL CYCLER & MANIFOLD SET (K772136)Physio-Control Corp.1977-12-20
SUCTION CANISTER (K771737)Bemis Health Care1977-12-20
PULSE GENERATOR, A-V SEQ. (K772202)Medtronic Vascular1977-12-20
SETUP WALKER OVER TOILET CONSTRUC. (K772270)Med Fusion Systems, Inc.1977-12-20
PEDIATRIC THYROXINE TEST SYS. T4 (K771609)Corning Medical & Scientific1977-12-20
SETUP WALKER ADJUSTABLE (K772269)Med Fusion Systems, Inc.1977-12-20
CULTURE COLLEC. TRANS. SYS., SINGLE WET (K772207)Precision Dynamics Corp.1977-12-20
ENDOTRACHEAL TUBE (K772138)Medline Industries, Inc.1977-12-20
CATHETER, CARDIOVASCULAR (K771823)Usci, Div. C.R. Bard, Inc.1977-12-20
WALKER FOLDING ADJUSTABLE (K772271)Med Fusion Systems, Inc.1977-12-20
RX PEDESTAL TABLE (K772283)General Electric Co.1977-12-15
LIQUID NITROGEN SPRAY UNIT (K772232)Gilmore Liquid Air Co.1977-12-15
NERVE STIMULATOR, ELEC. TRANSCUTANEOUS (K772224)Stimulation Technology, Inc.1977-12-15
HERPES I.D. TM TEST (K771445)Hyland Therapeutic Div., Travenol Laboratories1977-12-14
VESSEL-STABILIZER (K771702)Med General1977-12-13
CAUTERIES, HOT WIRE, DISP. (K772199)Intermedics, Inc.1977-12-13
CATHETER, SILICONE COATED (K772218)Concord Laboratories, Inc.1977-12-13
VESSEL-CLUDE (K771701)Med General1977-12-13
HAND CONTROL ACCESS.-ELECTROSURG. UNITS (K772235)Cameron-Miller, Inc.1977-12-13
PROBE, COAGULATION ACCESSORY (K772220)Kli1977-12-13
OPHTHALMOSCOPE, BINOCULAR, INDIRECT (K772214)Varian Assoc., Inc.1977-12-13
LAMP DELIVERY SYS.-PHOTOCOAGULATION (K772213)Varian Assoc., Inc.1977-12-13
OXYGENATOR, BUBBLE (K772237)Shiley, Inc.1977-12-13
AUTO SUTURE (K771589)U. S. Surgical Corp.1977-12-13
TEMPERATURE MONITOR (K772217)Hudson Oxygen Therapy Sales Co.1977-12-13
CULTURE COLLEC. TRANS. SYS., SINGLE WET (K772206)Precision Dynamics Corp.1977-12-09
CULTURE COLLEC. TRANS. SYS., DOUBLE WET (K772210)Precision Dynamics Corp.1977-12-09
CULTURE COLLEC. TRANS. SYS., DOUBLE WET (K772205)Precision Dynamics Corp.1977-12-09
CULTURE COLLEC. TRANS. SYS., SINGLE DRY (K772208)Precision Dynamics Corp.1977-12-09
MICROCULT-ID (K771672)Miles Laboratories, Inc.1977-12-09
SURGICAL GOWN, REINFORCED (K772182)Surgikos, Inc.1977-12-08
LIFECARE I.V. PUMP - MODEL III (K772094)Abbott Laboratories1977-12-08
PACER MONITOR, PULSE WIDTH (K772178)Survival Technology, Inc.1977-12-08
BIOLOGICAL/CHEMICAL INDICATOR (K772135)Amsco Co.1977-12-08
INTRAVENOUS INFUSION PUMP (K771300)Stewart-Naumann Laboratories1977-12-08
PATELLAR PROSTHESIS (K772225)Cutter Laboratories, Inc.1977-12-08
PLASTIC STOPCOCK W/ EXTENSION TUBE (K771911)Medon Corp.1977-12-08
DIGITAL THERMOMETER (K771935)Medical Networks1977-12-08
MEDI-JECTOR (K772129)Derata Corp.1977-12-08
YASARGIL ANEURYSM CLIPS (K772200)Aesculap Instruments Corp.1977-12-08
PH CALIBRATION BUFFERS (K772106)General Diagnostics1977-12-06
DYNAZYME TM II CARDIAK-MB (K772172)J.T. Baker Chemical Co.1977-12-06
LEE ASPIRATION NEEDLE (K771574)Radiation Development Co., Inc.1977-12-06
AUTOMATIC ANALYZER (K771662)Lachat Chemicals, Inc.1977-12-06
PHOSPHATE (K771906)Simmler & Son, Inc.1977-12-06
MICROBIOLOGICAL CULTURE MEDIUM (K771936)Scott Laboratories, Inc.1977-12-06
GLYCEROL SUBSTRATE (K771905)Simmler & Son, Inc.1977-12-06
ULTRACHEM PHOSPHORUS, 64973 (K772156)Harleco1977-12-06
AMES T-3 UPTAKE STRIP TEST (K772088)Miles Laboratories, Inc.1977-12-06
CRYOSURGICAL EQUIPMENT (K771320)A.S.M.O.T.1977-12-06
LIPASE (K771903)Simmler & Son, Inc.1977-12-06
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Every clearance here is in the API, with alerts when new ones post.