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
140953–140976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1987
BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH
K864659 · JLW
Bio Mega Diagnostic, Inc.
Chemistry · 68d
Cleared Feb 04, 1987
MODEL M402 EMG MONITOR
K864660 · IKN
Bio-Logic Devices
Neurology · 68d
Cleared Feb 04, 1987
UNIFAST CALCIUM TEST
K864661 · CIC
Sclavo, Inc.
Chemistry · 68d
Cleared Feb 04, 1987
CRYOTHERM
K864721 · ILJ
Grimm Scientific Industries, Inc.
Physical Medicine · 63d
Cleared Feb 04, 1987
CHUCK HANDLE
K864771 · GEI
New England Surgical Instrument Corp.
General & Plastic Surgery · 61d
Cleared Feb 04, 1987
BETAFLO 2000 PIGGYBACK SYSTEM
K864789 · LDR
Betaflo, Inc.
General Hospital · 58d
Cleared Feb 04, 1987
POIRIER POWERED WHEELCHAIR
K864791 · ITI
Roseburg SA
Physical Medicine · 58d
Cleared Feb 04, 1987
TSH MAB IRMA
K864839 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 57d
Cleared Feb 04, 1987
OMNI THERM TEMPERATURE MONITOR
K864853 · KPD
Omni Therm, Inc.
General Hospital · 55d
Cleared Feb 04, 1987
FERRIS DYNADERM PLUS
K865089 · FRO
Ferris Mfg. Corp.
General & Plastic Surgery · 36d
Cleared Feb 04, 1987
E-Z JECT INSULIN SYRINGE
K870018 · FMF
Can-Am Surgical Corp.
General Hospital · 33d
Cleared Feb 04, 1987
IV SECUREMENT DEVICE
K870020 · KGX
Avery Intl.
General & Plastic Surgery · 33d
Cleared Feb 04, 1987
SKYTRON MODEL 610-2
K870045 · INX
Skytron, Div. the Kmw Group, Inc.
Physical Medicine · 30d
Cleared Feb 04, 1987
T1365 (BIRD SEED AGAR SLANT)
K870057 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 28d
Cleared Feb 04, 1987
IV SECUREMENT DEVICE USING HYTREL THERMO. FILM
K870090 · KGX
Avery Intl.
General & Plastic Surgery · 26d
Cleared Feb 04, 1987
IV SECUREMENT DEVICE USING PCCE THERMO. FILM
K870091 · KGX
Avery Intl.
General & Plastic Surgery · 26d
Cleared Feb 04, 1987
SURGICAL DRAPES AND ACCESSORIES USING HYTREL FILM
K870122 · KKX
Avery Intl.
General Hospital · 23d
Cleared Feb 04, 1987
SURGICAL DRAPES AND ACCESSORIES USING PCCE FILM
K870123 · KKX
Avery Intl.
General Hospital · 23d
Cleared Feb 04, 1987
SURGICAL DRAPES AND ACCESSORIES USING PEBAX FILM
K870124 · KKX
Avery Intl.
General Hospital · 23d
Cleared Feb 04, 1987
EXTREMITY ELEVATOR
K870125 · HST
Orthopedic Systems, Inc.
Neurology · 23d
Cleared Feb 04, 1987
MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PRE
K870134 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 22d
Cleared Feb 04, 1987
KULTSURE
K870231 · LIO
Ncs Diagnostics, Inc.
Microbiology · 14d
Cleared Feb 03, 1987
INJET-100, FLUID INJECTOR
K861582 · KZE
Injet Medical Products, Inc.
General Hospital · 280d
Cleared Feb 03, 1987
2120 NON-INVASIVE BLOOD PRESSURE MONITOR W/CUFF
K861987 · DXN
Ohmeda Medical
Cardiovascular · 257d