FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
101713–101736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 1995
STA-COAG CONTROL [P] PLUS KIT
K952338 · GGC
American Bioproducts Co.
Hematology · 125d
Cleared Sep 21, 1995
CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE...
K952427 · CKA
Beckman Instruments, Inc.
Chemistry · 120d
Cleared Sep 21, 1995
OPTI-MAX INTERNAL-HEX ANGLED IMPLANT CROWN POST, 10 DEGREE & 20 DEGREE...
K952592 · DZE
Opti-Max
Dental · 108d
Cleared Sep 21, 1995
PRECEDER GUIDEWIRE
K953023 · DQX
Boston Scientific Corp
Cardiovascular · 84d
Cleared Sep 21, 1995
OXILINK (SMALL, MEDIUM, LARGE)
K953126 · DQA
Bci Intl., Inc.
Anesthesiology · 78d
Cleared Sep 21, 1995
BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE)
K953775 · DZE
Nobelpharma USA, Inc.
Dental · 38d
Cleared Sep 21, 1995
ABUTMENT
K953836 · DZE
Steri-Oss, Inc.
Dental · 37d
Cleared Sep 21, 1995
XLS-300 XENON LIGHT SOURCE
K953924 · GCT
Specialties of Surgery
Gastroenterology & Urology · 34d
Cleared Sep 21, 1995
POLY-LITE MODEL 1000
K954061 · EBZ
Pro-Den Systems, Inc.
Dental · 23d
Cleared Sep 20, 1995
IRON/TIBC REAGENT
K935712 · JIY
Horizon Diagnostics, Inc.
Chemistry · 659d
Cleared Sep 20, 1995
RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR
K941252 · DRT
Ansar
Cardiovascular · 554d
Cleared Sep 20, 1995
ROCHE CALIBRATOR SERUM
K942706 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 469d
Cleared Sep 20, 1995
RELAXPLUS
K951213 · HCC
Ultramind International , Ltd.
Neurology · 187d
Cleared Sep 20, 1995
AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II
K952720 · JPK
Aalto Scientific, Ltd.
Hematology · 97d
Cleared Sep 20, 1995
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR
K952862 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 90d
Cleared Sep 20, 1995
VACUTAINER PLUS TUBES
K953463 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 58d
Cleared Sep 20, 1995
ABUSCREEN ONLINE CONTROLS
K953739 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 44d
Cleared Sep 20, 1995
ABUSCREEN ONLINE DRUG FREE URINE
K953845 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 35d
Cleared Sep 19, 1995
ADI SYSTEM
K933825 · FRN
Abbott Laboratories
General Hospital · 775d
Cleared Sep 19, 1995
MARSAM MODEL 2000 NEBULIZER
K933961 · CAF
Marsam Pharmaceuticals, Inc.
Anesthesiology · 767d
Cleared Sep 19, 1995
EBNA IGG ELISA TEST
K935730 · LLM
Gull Laboratories, Inc.
Microbiology · 657d
Cleared Sep 19, 1995
AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS
K940320 · BTQ
Ad-Tech Medical Instrument Corp
Anesthesiology · 603d
Cleared Sep 19, 1995
CROSSVENT-4 VENTILATOR
K942938 · CBK
Bio-Med Devices, Inc.
Anesthesiology · 454d
Cleared Sep 19, 1995
DANTEC KEYPOINT
K944547 · GWF
Mckenna & Cuneo
Neurology · 369d