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
123073–123096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1991
M. CAT. BUTYRATE DISC
K905666 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 70d
Cleared Feb 26, 1991
COULTER DART AST (GOT) REAGENT
K905771 · CIT
Coulter Electronics, Inc.
Chemistry · 61d
Cleared Feb 26, 1991
ALBUMIN REAGENT SET
K905776 · CJW
Biochemical Trade, Inc.
Toxicology · 61d
Cleared Feb 26, 1991
HFQ SERIES CONTROLS AND GENERATORS
K905799 · IZO
Bennett X-Ray Corp.
Radiology · 88d
Cleared Feb 26, 1991
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI
K905820 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 57d
Cleared Feb 26, 1991
PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200
K910105 · GFT
International Technidyne Corp.
Hematology · 54d
Cleared Feb 26, 1991
CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL TEST
K910240 · CHH
Crystal Diagnostics, Inc.
Chemistry · 35d
Cleared Feb 26, 1991
LAPAROSCOPIC ASPIRATION PROBE
K910340 · HET
Davol, Inc.
Obstetrics & Gynecology · 29d
Cleared Feb 26, 1991
ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL
K910416 · LGD
Abbott Laboratories
Microbiology · 27d
Cleared Feb 26, 1991
BIOCLONE'S ELEGANCE HCG ELISA KIT
K910420 · JHI
Bioclone Australia Pty , Ltd.
Chemistry · 27d
Cleared Feb 26, 1991
J&B OPTICAL FRAMES
K910626 · HQZ
J & B Optical, Inc.
Ophthalmic · 14d
Cleared Feb 25, 1991
MODIFIED LIFEPAK 9 MONITOR/DEFIBRILLATOR
K902288 · LDD
Physio-Control Corp.
Cardiovascular · 279d
Cleared Feb 25, 1991
EMBOLECTOMY CATHETER
K902327 · DXE
Clincal Instruments Corp.
Cardiovascular · 277d
Cleared Feb 25, 1991
INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH.
K902627 · KRB
Biometric Research Institute, Inc.
Cardiovascular · 257d
Cleared Feb 25, 1991
INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT
K902628 · DXG
Biometric Research Institute, Inc.
Cardiovascular · 257d
Cleared Feb 25, 1991
PCM ANESTHESIA
K903991 · BSZ
Siemens Life Support Systems
Anesthesiology · 180d
Cleared Feb 25, 1991
SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST.
K904117 · BZG
Dawn Medical
Anesthesiology · 172d
Cleared Feb 25, 1991
SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST.
K904118 · BZG
Dawn Medical
Anesthesiology · 172d
Cleared Feb 25, 1991
MODEL 4222 AMBULATORY ECG MONITOR
K904250 · DXH
Byrncrest Global, Inc.
Cardiovascular · 161d
Cleared Feb 25, 1991
EER ERECTION ENHANCED RESPONDER
K904406 · LKY
Eer, Inc.
Gastroenterology & Urology · 154d
Cleared Feb 25, 1991
QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE
K904582 · DQX
Meadox Surgimed, Inc.
Cardiovascular · 139d
Cleared Feb 25, 1991
VISTA VIEWING STATION
K904975 · DXK
Prism Imaging, Inc.
Cardiovascular · 116d
Cleared Feb 25, 1991
CINE'VIEW - STRESS ECHO & IMAGE REVIEW
K904976 · DXK
Prism Imaging, Inc.
Cardiovascular · 116d
Cleared Feb 25, 1991
CINE/VIEW PLUS - CARDIOLOGY WORKSTATION
K904977 · DXK
Prism Imaging, Inc.
Cardiovascular · 116d