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
103345–103368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 1995
STERI-OSS SCALER FOR DENTAL IMPLANTS
K943681 · DZE
Steri-Oss, Inc.
Dental · 262d
Cleared Apr 14, 1995
SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM
K943883 · HIS
Aladan Corp.
Obstetrics & Gynecology · 248d
Cleared Apr 14, 1995
ARTHREX CANCELLOUS SCREW AND WASHER
K945426 · HWC
Arthrex, Inc.
Orthopedic · 161d
Cleared Apr 14, 1995
LEUR TIP CAP, VLT CAP(TM)
K945454 · JKA
Martell Medical Products, Inc.
Chemistry · 158d
Cleared Apr 14, 1995
MICOS MICROPULSE(TM) ALTERNATING PRESSURE MATTRESS
K945629 · FNM
Micos Medical Systems
General Hospital · 149d
Cleared Apr 14, 1995
SPETZLER PIN
K945639 · HTY
Howmedica Corp.
Orthopedic · 149d
Cleared Apr 14, 1995
SURESHARP
K950159 · FMI
Gainor Medical U.S.A., Inc.
General Hospital · 87d
Cleared Apr 14, 1995
PREMIER EHEC
K950167 · GNA
Meridian Diagnostics, Inc.
Microbiology · 87d
Cleared Apr 14, 1995
MULTIPLE (IZON DBS & URINE COLLECTION KIT)
K950257 · JXA
Izon Business Products, Inc.
Chemistry · 81d
Cleared Apr 14, 1995
SCIMED(R) CHOICE(TM) PT EXCHANGE PTCA GUIDE WIRE
K950266 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 81d
Cleared Apr 14, 1995
STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA
K950308 · JXS
Solarcare Technologies Corp,Inc.
Toxicology · 79d
Cleared Apr 14, 1995
CORDIS STEERABLE GUIDEWIRES
K950316 · DQX
Cordis Corp.
Cardiovascular · 78d
Cleared Apr 14, 1995
AMOXICILLIN/CLAVULANIC ACID 2/1
K950328 · JWY
Ab Biodisk North America, Inc.
Microbiology · 85d
Cleared Apr 14, 1995
SYSTEM 22 VALVE
K950397 · BYE
Turnkey Intergration USA, Inc.
Anesthesiology · 72d
Cleared Apr 14, 1995
GAUZE, NONABSORABLE, NON-MEDICATED (INTERNAL SPONGE)
K950462 · EFQ
Spring Intl., Inc.
General & Plastic Surgery · 70d
Cleared Apr 14, 1995
OXYGEN REGULATOR
K950777 · CAN
Mada Medical Products, Inc.
Anesthesiology · 52d
Cleared Apr 14, 1995
ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM
K951000 · LPH
Joint Medical Products Corp.
Orthopedic · 42d
Cleared Apr 14, 1995
DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING
K951345 · BZA
Catheter Research, Inc.
Anesthesiology · 22d
Cleared Apr 14, 1995
PORTA-SCREEN SPIROMETER
K951367 · BZG
S & M Instrument Co.
Anesthesiology · 18d
Cleared Apr 14, 1995
RESOUND PERSONAL HEARING SYSTEM BT2/S-E
K951374 · ESD
Resound Corp.
Ear, Nose, Throat · 18d
Cleared Apr 14, 1995
RESOUND PERSONAL HEARING SYSTEM ED3/S-E
K951375 · ESD
Resound Corp.
Ear, Nose, Throat · 18d
Cleared Apr 14, 1995
RESOUND PERSONAL HEARING SYSTEM BT2/S SERIES W/REMOTE CONTROL OPTION
K951376 · ESD
Resound Corp.
Ear, Nose, Throat · 18d
Cleared Apr 14, 1995
RESOUND PERSONAL HEARING SYSTEM BTP/S-A W/REMOTE CONTROL OPTION
K951377 · ESD
Resound Corp.
Ear, Nose, Throat · 18d
Cleared Apr 14, 1995
LORREX GAUZE PADS (1'S) AND LORREX GAUZE SPONGES - STERILE 2'S AND STERILE...
K951418 · EFQ
Lorons International Corp.
General & Plastic Surgery · 17d