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
102889–102912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 1995
IMWXDOP IR
K944196 · JAF
Imex Medical Systems, Inc.
Radiology · 256d
Cleared May 12, 1995
ECG MONITOR
K944262 · DRT
Fukuda Denshi USA, Inc.
Cardiovascular · 255d
Cleared May 12, 1995
MECHANICAL WHEELCHAIR- AVENGER
K945148 · IOR
Colours 'N Motion
Physical Medicine · 204d
Cleared May 12, 1995
MECHANICAL WHEELCHAIR- CHALLENGER
K945149 · IOR
Colours 'N Motion
Physical Medicine · 204d
Cleared May 12, 1995
MECHANICAL WHEERCHAIR- ECLIPSE
K945150 · IOR
Colours 'N Motion
Physical Medicine · 204d
Cleared May 12, 1995
MECHANICAL WHEELCHAIR- G-FORCE
K945151 · IOR
Colours 'N Motion
Physical Medicine · 204d
Cleared May 12, 1995
MECHANICAL WHEELCHAIR- LIL DIPPER
K945153 · IOR
Colours 'N Motion
Physical Medicine · 204d
Cleared May 12, 1995
MECHANICAL WHEELCHAIR 890.3850
K945175 · IOR
Lumex, Inc.
Physical Medicine · 203d
Cleared May 12, 1995
ALL-IN-ONE TWO CHAMBER CONTAINER
K945193 · KPE
Baxter Healthcare Corp
General Hospital · 200d
Cleared May 12, 1995
HYDROGEL DRESSING
K945217 · MGQ
O.R. Resources, Inc.
General & Plastic Surgery · 198d
Cleared May 12, 1995
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND...
K945907 · FGC
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 161d
Cleared May 12, 1995
SIMULIX-HP
K946128 · KPQ
Oldelft Corp. of America
Radiology · 148d
Cleared May 12, 1995
MINI IMAGER
K950423 · LMC
Regulatory Management Services
Radiology · 99d
Cleared May 12, 1995
DANEK RIGID ARTHROSCOPE
K950501 · HRX
Sofamor Danek USA,Inc.
Orthopedic · 95d
Cleared May 12, 1995
KSEA DISPOSABLE TUBING SET FOR THE ARTHROPUMP
K950561 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 93d
Cleared May 12, 1995
INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP
K950632 · GCJ
Innerdyne, Inc.
General & Plastic Surgery · 88d
Cleared May 12, 1995
INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP:
K950658 · GCJ
Innerdyne, Inc.
General & Plastic Surgery · 88d
Cleared May 12, 1995
CHAMPION
K950815 · IOR
Kleinfeld, Kaplan and Becker
Physical Medicine · 79d
Cleared May 12, 1995
PERFECT, ENT SET, PRAKTIKANT, DE LUXE
K950913 · ERA
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 78d
Cleared May 12, 1995
RESOUND ED4-C CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND...
K951067 · ESD
Resound Corp.
Ear, Nose, Throat · 65d
Cleared May 12, 1995
RESOUND ED4-M MINI-CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION...
K951068 · ESD
Resound Corp.
Ear, Nose, Throat · 65d
Cleared May 12, 1995
CRYSTAL
K951168 · HQY
Crystal Optical Co., Ltd.
Ophthalmic · 58d
Cleared May 12, 1995
RYDER CONTACT LENS CASE
K951181 · LRX
Bradstreet Clinical Research Assoc.,...
Ophthalmic · 57d
Cleared May 12, 1995
OTI MODEL 78-60
K951184 · HJO
Oti Medical, LLC
Ophthalmic · 57d