FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
86497–86520 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 1999
LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789
K990858 · GGN
Bio-Rad
Hematology · 37d
Cleared Apr 21, 1999
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY
K990915 · DHN
Stellar Bio Systems, Inc.
Immunology · 34d
Cleared Apr 21, 1999
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY
K990916 · KTL
Stellar Bio Systems, Inc.
Immunology · 34d
Cleared Apr 21, 1999
S575 INTRAORAL DOCKING DENTAL CAMERA
K990948 · EIA
Sopro
Dental · 30d
Cleared Apr 20, 1999
QUICKDRAW VENOUS CANNULA
K981995 · DWF
Heartport, Inc.
Cardiovascular · 316d
Cleared Apr 20, 1999
EEG ELECTRODES MODEL 445 SERIES
K982053 · GXY
Class A Ent.
Neurology · 313d
Cleared Apr 20, 1999
FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095
K983338 · JAQ
Nucletron Corp.
Radiology · 209d
Cleared Apr 20, 1999
PHOTOTHERAPY LAMP
K984589 · LBI
Medela, Inc.
General Hospital · 117d
Cleared Apr 20, 1999
ENDOMETRIAL SAMPLER
K990387 · HHK
U.A. Medical Products, Inc.
Obstetrics & Gynecology · 71d
Cleared Apr 20, 1999
CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50
K990754 · KHS
Diagnostic Chemicals , Ltd.
Chemistry · 43d
Cleared Apr 20, 1999
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K990939 · CGA
Selfcare, Inc.
Chemistry · 29d
Cleared Apr 20, 1999
FLEXPLUG
K991130 · LZU
Eagle Vision, Inc.
Ophthalmic · 18d
Cleared Apr 19, 1999
RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT
K980903 · JXG
Radionics, Inc.
Neurology · 405d
Cleared Apr 19, 1999
DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111
K990159 · FJI
Dynamic Technology Corp.
Gastroenterology & Urology · 90d
Cleared Apr 19, 1999
MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
K990189 · FLE
Midmark Corp.
General Hospital · 89d
Cleared Apr 19, 1999
SMARTRECORDER, MODEL 2500
K990199 · MNR
Respironics, Inc.
Anesthesiology · 88d
Cleared Apr 19, 1999
CARESIDE CKMB
K990434 · JHS
Careside, Inc.
Chemistry · 67d
Cleared Apr 19, 1999
CARESIDE CK
K990439 · JHS
Careside, Inc.
Chemistry · 67d
Cleared Apr 19, 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA...
K990972 · DSI
Hewlett-Packard GmbH
Cardiovascular · 27d
Cleared Apr 16, 1999
COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER
K983830 · LIT
Mallinckroot, Inc.
Cardiovascular · 168d
Cleared Apr 16, 1999
BEACON, MODEL 211060
K983948 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 162d
Cleared Apr 16, 1999
`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH
K984446 · KXK
Urocor, Inc.
Radiology · 123d
Cleared Apr 16, 1999
NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES
K990031 · LOS
Nihon Kohden America, Inc.
Cardiovascular · 101d
Cleared Apr 16, 1999
BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S...
K990147 · HIN
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 87d