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
80905–80928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 2000
BUFFLIGHT CLT SURGICAL LASER SYSTEM
K000727 · GEX
Y-Beam Technologies, Inc.
General & Plastic Surgery · 197d
Cleared Sep 19, 2000
CANDELA SPTL-1B PULSED DYE LASER
K001093 · GEX
Candela Corp.
General & Plastic Surgery · 168d
Cleared Sep 19, 2000
PROSTEC 125I BRANCHYTHERAPY SNAPSEED
K001366 · KXK
Prostec, LLC
Radiology · 172d
Cleared Sep 19, 2000
OCCU-FLO PUNCTUM PLUGS
K001768 · LZU
U.S. Iol, Inc.
Ophthalmic · 99d
Cleared Sep 19, 2000
BABY DOPPLEX 4002-TWINS, MODEL BD4002
K001882 · HGM
Huntleigh Healthcare, Inc.
Obstetrics & Gynecology · 90d
Cleared Sep 19, 2000
POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE...
K001901 · LJS
C.R. Bard, Inc.
General Hospital · 89d
Cleared Sep 19, 2000
KSEA PERCUTANEOUS FORAMINOSCOPY SET
K001918 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 88d
Cleared Sep 19, 2000
PAIN CARE 3000
K002073 · MEB
Breg, Inc.
General Hospital · 71d
Cleared Sep 19, 2000
ULTRASORB SUTURE ANCHOR
K002413 · MAI
Li Medical Technologies, Inc.
Orthopedic · 43d
Cleared Sep 19, 2000
ASCENT KNEE SYSTEM
K002678 · JWH
Biomet, Inc.
Orthopedic · 22d
Cleared Sep 19, 2000
ASCENT XXL OPEN BOX FEMORAL COMPONENT
K002735 · JWH
Biomet, Inc.
Orthopedic · 18d
Cleared Sep 19, 2000
BIS ENGINE
K002837 · OLW
Aspect Medical Systems, Inc.
Neurology · 7d
Cleared Sep 18, 2000
RAEBBITT/EVOLUTION POWERED WHEELCHAIR
K000678 · ITI
Otto Bock Orthopedic Industry, Inc.
Physical Medicine · 202d
Cleared Sep 18, 2000
SERAGARD VASCULAR ACCESS PATCH
K001175 · FMI
Platinum Services, Inc.
General Hospital · 160d
Cleared Sep 18, 2000
ACTI-FLEX IV ADMINISTRATION SET
K001599 · FPA
R-Group Intl.
General Hospital · 117d
Cleared Sep 18, 2000
DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE
K001869 · IKT
Medicotest A/S
Neurology · 90d
Cleared Sep 18, 2000
LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)
K002255 · CCT
Wolfe Tory Medical, Inc.
Anesthesiology · 55d
Cleared Sep 18, 2000
MODIFICATION TO PANAVIA F
K002322 · EMA
Kuraray America, Inc.
Dental · 49d
Cleared Sep 18, 2000
PELVX GELLHORN VAGINAL PESSARY 603-608
K002329 · HHW
Deschutes Medical Products, Inc.
Obstetrics & Gynecology · 48d
Cleared Sep 18, 2000
QUEST MPS BACK-UP SYSYEM
K002366 · DWF
Quest Medical, Inc.
Cardiovascular · 53d
Cleared Sep 18, 2000
COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF...
K002385 · MQL
Cook Ob/Gyn
Obstetrics & Gynecology · 45d
Cleared Sep 18, 2000
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD...
K002540 · JJX
Bionostics, Inc.
Chemistry · 33d
Cleared Sep 18, 2000
6060 MULTI-THERAPY PUMP, MODEL 2M9832
K002679 · FRN
Baxter Healthcare Corp
General Hospital · 21d
Cleared Sep 18, 2000
HL168T
K002750 · DXN
Health & Life Co., Ltd.
Cardiovascular · 13d