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
131929–131952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1989
VISUWELL REAGIN TEST 960 TEST KIT
K885298 · GMP
Allelix Diagnostics, Inc.
Microbiology · 78d
Cleared Mar 15, 1989
AML BOWED FEMORAL HIP
K885338 · JDI
Depuy, Inc.
Orthopedic · 77d
Cleared Mar 15, 1989
CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER
K890060 · LZO
Depuy, Inc.
Orthopedic · 65d
Cleared Mar 15, 1989
MICROLASE 8 0 0 (OPHTHALMIC LASER)
K890086 · HQF
Keeler Instruments, Inc.
Ophthalmic · 64d
Cleared Mar 15, 1989
ENGSTROM ELIZA + CO2 ANALYZER
K890112 · CCK
Gambro, Inc.
Anesthesiology · 63d
Cleared Mar 15, 1989
RADIOLUCENT ECG ELECTRODE MODEL NO: 1680
K890201 · DRX
Medtronic Vascular
Cardiovascular · 57d
Cleared Mar 15, 1989
HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES
K890281 · LSR
Cambridge Bioscience Corp.
Microbiology · 57d
Cleared Mar 15, 1989
USCI DISP. Y-CONNECTOR W/MODIFIED TUOHY-BORST ADAP
K890325 · LIT
C.R. Bard, Inc.
Cardiovascular · 51d
Cleared Mar 15, 1989
RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109)
K890414 · JJY
Amersham Corp.
Chemistry · 50d
Cleared Mar 15, 1989
RIATRAC PLUS
K890470 · JJY
Bd Becton Dickinson Vacutainer...
Chemistry · 43d
Cleared Mar 15, 1989
APEC GLUCOSE ANALYZER
K890524 · CGA
Amdev, Inc.
Chemistry · 41d
Cleared Mar 15, 1989
BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES
K890566 · CAE
Medi-Source, Inc.
Anesthesiology · 37d
Cleared Mar 15, 1989
EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT
K890619 · GFO
Elite Diagnostic , Ltd.
Hematology · 36d
Cleared Mar 15, 1989
MEDILOG 9000-II AMBULATORY RECORDER
K890647 · DSH
Oxford Medilog, Inc.
Cardiovascular · 33d
Cleared Mar 15, 1989
ABUSCREEN FP FOR PHENCYCLIDINE
K890882 · LCL
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Mar 15, 1989
ABUSCREEN FP BUFFER REAGENT
K890883 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Mar 15, 1989
ABUSCREEN FP FOR MORPHINE
K890888 · DJG
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Mar 15, 1989
SYSTEM 3000 FLUIDIZED AIR BED
K890935 · IOQ
Dermanetics Corp.
Physical Medicine · 19d
Cleared Mar 14, 1989
BRYMASCAN-A
K881336 · IYO
Brymill Corp.
Radiology · 350d
Cleared Mar 14, 1989
NORLAND MODEL XR-26 X-RAY BONE DENSITOMETER
K881865 · KGI
Norland Corp.
Radiology · 314d
Cleared Mar 14, 1989
FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY
K884047 · LYF
Disease Detection International, Inc.
Microbiology · 169d
Cleared Mar 14, 1989
CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER
K884552 · CAZ
Arrow Intl., Inc.
Anesthesiology · 134d
Cleared Mar 14, 1989
SURGICAL GLOVES
K884622 · KGO
Globe Ent., Inc.
General Hospital · 130d
Cleared Mar 14, 1989
VISTA MR 2055 HP SYSTEM
K885047 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 98d