FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
132049–132072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 1989
SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES
K884528 · KXT
Heraeus Kulzer, Inc.
Chemistry · 131d
Cleared Mar 08, 1989
ASPARTATE AMINOTRANSFERASE (AST)
K884724 · CIT
Catachem, Inc.
Chemistry · 118d
Cleared Mar 08, 1989
DELFIA SHBG KIT
K884809 · CDZ
Pharmacia, Inc.
Chemistry · 111d
Cleared Mar 08, 1989
MODEL 1000 ELECTRONIC CLINICAL THERMOMETER
K885187 · FLL
Mon-A-Therm, Inc.
General Hospital · 84d
Cleared Mar 08, 1989
FLIPSCREEN (TM) TOTAL E IMMUNOASSAY
K885307 · DGC
Alerchek, Inc.
Immunology · 71d
Cleared Mar 08, 1989
VAC-RITE
K885334 · GCX
Bd Becton Dickinson Vacutainer...
General Hospital · 70d
Cleared Mar 08, 1989
ADMS BIOPSY NEEDLE
K890203 · FCG
Advanced Diagnostic Medical Systems,...
Gastroenterology & Urology · 50d
Cleared Mar 08, 1989
ALKALINE PHOSPHATASE ISOENZYME REAGENTS
K890269 · CIN
Beckman Instruments, Inc.
Chemistry · 49d
Cleared Mar 08, 1989
TOTAL PROTEIN REAGENT
K890317 · CEK
Medical Analysis Systems, Inc.
Chemistry · 44d
Cleared Mar 08, 1989
BIOPSY NEEDLE GUIDE ATTACHMENT
K890327 · FCG
Elscint, Inc.
Gastroenterology & Urology · 44d
Cleared Mar 08, 1989
BIOTROL IRON REAGENT
K890395 · JIY
Biotrol, USA, Inc.
Chemistry · 42d
Cleared Mar 08, 1989
SHAPE-ACTIO URINALYSIS CONTROLS
K890442 · JJY
Actio, Inc.
Chemistry · 40d
Cleared Mar 08, 1989
MODIFIED MINIMED MDL404-SP/504-S DRUG INSULIN PUMP
K890457 · FRN
Medtronic Minimed
General Hospital · 37d
Cleared Mar 08, 1989
MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1
K890534 · JJW
Fisher Scientific Co., LLC
Chemistry · 41d
Cleared Mar 08, 1989
ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT
K890645 · CHP
Serono-Baker Diagnostics, Inc.
Chemistry · 28d
Cleared Mar 08, 1989
STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE
K890669 · LBR
Norfolk Scientific, Inc.
Chemistry · 27d
Cleared Mar 08, 1989
ALLEVYN TRACHEOSTOMY DRESSING
K890748 · NAD
Smith & Nephew United, Inc.
General & Plastic Surgery · 23d
Cleared Mar 06, 1989
RESPIRATORY AIRWAY TUBE MONITOR (RATM)
K883158 · BZQ
Vascucare, Inc.
Anesthesiology · 223d
Cleared Mar 06, 1989
SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL
K884106 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 158d
Cleared Mar 06, 1989
EURO-MED LIGHT TOUCH BIOPSY PUNCH
K884740 · EME
Buckman Co., Inc.
Dental · 112d
Cleared Mar 06, 1989
SPINAL ANESTHESIA TRAY
K885277 · CAZ
Preferred Medical Products
Anesthesiology · 73d
Cleared Mar 06, 1989
TOTAL BILIRUBIN REAGENT, CONCENTRATED
K890070 · CIG
Trace Scientific , Ltd.
Chemistry · 56d
Cleared Mar 06, 1989
THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4
K890675 · CZW
Unipath , Ltd.
Immunology · 25d
Cleared Mar 03, 1989
STONY BROOK MODEL EECP-MC1
K882401 · DRN
Stony Brook Trading and Development...
Cardiovascular · 266d