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
125233–125256 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 1990
ENDOCARDIAL SCREW-IN LEAD MODEL 1028T
K902147 · DTB
Pacesetter Systems
Cardiovascular · 63d
Cleared Jul 17, 1990
MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT
K902194 · DJG
Immunotech Corp.
Toxicology · 62d
Cleared Jul 17, 1990
MODIFIED OVUGEN
K902208 · CEP
Biogenex Laboratories
Chemistry · 62d
Cleared Jul 17, 1990
LVM QUALITY CONTROL SERUM
K902235 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 61d
Cleared Jul 17, 1990
OPTI-RAY SUNGLASSES
K902414 · HQY
Opti-Ray, Inc.
Ophthalmic · 47d
Cleared Jul 17, 1990
CALCIUM:ARSENAZO III
K902476 · CJY
Amresco, Inc.
Chemistry · 42d
Cleared Jul 17, 1990
CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432
K902479 · CIC
Amresco, Inc.
Chemistry · 42d
Cleared Jul 17, 1990
ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT
K902560 · CJE
Roche Diagnostic Systems, Inc.
Chemistry · 36d
Cleared Jul 17, 1990
COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER
K902671 · CAC
Cobe Laboratories, Inc.
Anesthesiology · 29d
Cleared Jul 17, 1990
HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND
K902673 · JJY
Hi Chem, Inc.
Chemistry · 29d
Cleared Jul 17, 1990
BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT
K902801 · CIG
Beckman Instruments, Inc.
Chemistry · 20d
Cleared Jul 16, 1990
ABBOTT LIFECARE 4100 PCA INFUSER
K895710 · FRN
Abbott Laboratories
General Hospital · 294d
Cleared Jul 16, 1990
CLOSED DISCONNECT SYSTEM
K900106 · KDJ
Delmed, Inc.
Gastroenterology & Urology · 188d
Cleared Jul 16, 1990
WILSON-COOK ESOPHAGEAL MOTILITY CATHETER
K900239 · KLA
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 180d
Cleared Jul 16, 1990
1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT)
K900577 · BTM
Intertech Resources, Inc.
Anesthesiology · 159d
Cleared Jul 16, 1990
GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER
K900918 · KDI
Gambro, Inc.
Gastroenterology & Urology · 139d
Cleared Jul 16, 1990
GASTROINTESTINAL CYTOLOGY BRUSH
K901435 · FDX
Telemed Systems, Inc.
Gastroenterology & Urology · 112d
Cleared Jul 16, 1990
CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275)
K901630 · GYB
Henley Intl.
Neurology · 98d
Cleared Jul 16, 1990
ANAEROBIC ACCU-CULSHURE(TM)
K901645 · JTX
Medical Laboratory Automation...
Microbiology · 98d
Cleared Jul 16, 1990
PTH-MM II 125I RADIOIMMUNOASSAY (RIA)
K901711 · CEW
Incstar Corp.
Chemistry · 94d
Cleared Jul 16, 1990
MODIFIED FLOCATH PULMONARY ARTERY CATHETER
K901733 · DPW
Cardio Metrics, Inc.
Cardiovascular · 90d
Cleared Jul 16, 1990
CODMAN SUCTION PATTIE
K901937 · GCX
Codman & Shurtleff, Inc.
General Hospital · 77d
Cleared Jul 16, 1990
OLYMPIC BILI-LITE-PAD(TM)
K901987 · LBI
Olympic Medical Corp.
General Hospital · 75d
Cleared Jul 16, 1990
WILSON-COOK SYRINGE HOLDERS
K902107 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 69d