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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
85993–86016 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 16, 1999
DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION
K990248 · IYO
Dicomit Imaging Systems Corp.
Radiology · 80d
Cleared Apr 16, 1999
S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV...
K990281 · LPL
Nissel , Ltd.
Ophthalmic · 78d
Cleared Apr 16, 1999
KINGLI ACUPUNCTURE NEEDLE
K990406 · MQX
United Pacific Co., Ltd.
General Hospital · 66d
Cleared Apr 16, 1999
STRAUMANN EXTRAORAL IMPLANT SYSTEM
K990458 · KCZ
Straumann USA
General & Plastic Surgery · 63d
Cleared Apr 16, 1999
SHIMADZU CEILING TUBE SUPPORT CH-30GH
K990715 · KPR
Shimadzu Corp.
Radiology · 43d
Cleared Apr 16, 1999
REVISED C-REACTIVE PROTEIN CALIBRATOR
K990824 · JIT
Dade Behring, Inc.
Immunology · 35d
Cleared Apr 16, 1999
REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE
K990825 · DCN
Dade Behring, Inc.
Immunology · 35d
Cleared Apr 16, 1999
LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405
K990928 · DIE
Bio-Rad
Toxicology · 28d
Cleared Apr 16, 1999
CONVERTORS SURGICAL GOWNS
K991034 · FYA
Allegiance Healthcare Corp.
General Hospital · 18d