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
130033–130056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1989
70-X/RVG (RADIOVISIOGRAPHY)
K881133 · EHO
Trophy Radiologie
Radiology · 491d
Cleared Jul 20, 1989
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K890194 · JOH
Shiley, Inc.
Anesthesiology · 184d
Cleared Jul 20, 1989
STAT CHEM SYSTEM
K891050 · CGA
Diagnostic Resources, Inc.
Chemistry · 142d
Cleared Jul 20, 1989
MINICLINIC OVULATION PREDICTION TEST
K891762 · CEP
Vanguard Biomedical Corp.
Chemistry · 118d
Cleared Jul 20, 1989
THE POUCH GROIN & ABDOMINAL STRESS AID
K892379 · FSD
Kuhn Industries
General Hospital · 105d
Cleared Jul 20, 1989
ACID PHOSPHATASE REAGENT
K892393 · CKB
Medical Analysis Systems, Inc.
Chemistry · 104d
Cleared Jul 20, 1989
FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER
K892410 · DXE
Baxter Healthcare Corp
Cardiovascular · 104d
Cleared Jul 20, 1989
CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE
K892500 · JGS
Ciba Corning Diagnostics Corp.
Chemistry · 98d
Cleared Jul 20, 1989
TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS
K892668 · CIG
Catachem, Inc.
Chemistry · 98d
Cleared Jul 20, 1989
SOFTWARE RELEASE 1.3 FOR THE SL SERIES LINEAR ACCE
K892845 · IYE
Philips Medical Systems, Inc.
Radiology · 93d
Cleared Jul 20, 1989
PANCREATIC A-AMYLASE PNP
K892848 · JFJ
Boehringer Mannheim Corp.
Chemistry · 93d
Cleared Jul 20, 1989
ULCERCARE
K892867 · DWL
Jobst Institute, Inc.
General Hospital · 92d
Cleared Jul 20, 1989
BIAD NUCLEAR IMAGING SYSTEM
K892875 · KPS
Trionix Research Laboratory, Inc.
Radiology · 92d
Cleared Jul 20, 1989
TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES
K892929 · CHJ
Technicon Instruments Corp.
Chemistry · 90d
Cleared Jul 20, 1989
1 VIDEO TAPE RECORDER MODEL BK-224 H
K892934 · OXO
Perkins Mfg. Co.
Radiology · 90d
Cleared Jul 20, 1989
REP(TM) CK-2 STAT KIT, CAT. NO. 3074
K893007 · CGS
Helena Laboratories
Chemistry · 87d
Cleared Jul 20, 1989
DOCUMENT(TM) URIC ACID LINEARITY TEST SET
K893139 · JIT
Casco Standards
Chemistry · 86d
Cleared Jul 20, 1989
BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME
K893269 · CGS
Beckman Instruments, Inc.
Chemistry · 79d
Cleared Jul 20, 1989
YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP
K893409 · BZT
Yellow Springs Instrument Co., Inc.
Anesthesiology · 71d
Cleared Jul 20, 1989
ALT REAGENT (PROCEDURE NUMBER 159)
K893560 · CKA
Sigma Chemical Co.
Chemistry · 72d
Cleared Jul 20, 1989
DADE LIPID-TROL
K893580 · JJY
Baxter Healthcare Corp
Chemistry · 72d
Cleared Jul 20, 1989
14 COLOR VIDEO DISPLAY 211-260-010
K893585 · LLZ
Mennen Medical, Inc.
Radiology · 72d
Cleared Jul 20, 1989
MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM
K893637 · IZL
Shimadzu Medical Systems
Radiology · 69d
Cleared Jul 20, 1989
COBAS FARA CENTRIFUGAL ANALYZER
K893641 · JJG
Roche Diagnostic Systems, Inc.
Chemistry · 66d