FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
89041–89064 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 1998
SONOPSY LA SYSTEM
K980423 · IYO
Neovision Corp.
Radiology · 185d
Cleared Aug 07, 1998
EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET
K980504 · DYB
Schneider/Namic
Cardiovascular · 179d
Cleared Aug 07, 1998
MEDTRONIC ZUMA GUIDING CATHETER
K981198 · DQY
Medtronics Interventional Vascular
Cardiovascular · 127d
Cleared Aug 07, 1998
STEALTHSTATION SYSTEM DIGITIZER CHANGE
K981686 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 86d
Cleared Aug 07, 1998
IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW
K981790 · IYE
Elekta Oncology Systems, Ltd.
Radiology · 79d
Cleared Aug 07, 1998
POS T-7000
K981805 · HCS
Pos Technologies, Inc.
Neurology · 78d
Cleared Aug 07, 1998
SLEEP MANAGEMENT SYSTEM
K981844 · HCC
Rmp, Inc.
Neurology · 73d
Cleared Aug 07, 1998
LIGHT SABER ASPIRATION NEEDLE
K982018 · FMF
Minrad, Inc.
General Hospital · 60d
Cleared Aug 07, 1998
RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201
K982130 · GEI
New Deantronics, Ltd.
General & Plastic Surgery · 51d
Cleared Aug 07, 1998
INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER
K982249 · EWO
Idem (Int'L Dist. of Electronics For...
Ear, Nose, Throat · 42d
Cleared Aug 07, 1998
MICRO21 WITH URINE SEDIMENT ANALYSIS
K982301 · JOY
Triangle Biomedical Sciences, Inc.
Hematology · 37d
Cleared Aug 07, 1998
DIAGNOSTIC ULTRASOUND SYSTEM
K982498 · IYN
Volumetrics Medical Imaging, Inc.
Radiology · 21d
Cleared Aug 07, 1998
CAREDOP II
K982635 · JAF
Nicolet Biomedical
Radiology · 25d
Cleared Aug 07, 1998
MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM
K982686 · MNI
Sofamor Danek USA,Inc.
Orthopedic · 4d
Cleared Aug 06, 1998
SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM
K974539 · MNT
Resmed, Ltd.
Anesthesiology · 246d
Cleared Aug 06, 1998
5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE...
K974847 · MBI
Arthrex, Inc.
Orthopedic · 220d
Cleared Aug 06, 1998
MINI-CISER
K974848 · BWF
Hougen Mfg., Inc.
Anesthesiology · 220d
Cleared Aug 06, 1998
X-AIR-CISER
K974849 · BYI
Hougen Mfg., Inc.
Anesthesiology · 220d
Cleared Aug 06, 1998
IMAGE VUE EEG
K980477 · OLX
Sam Technology, Inc.
Neurology · 181d
Cleared Aug 06, 1998
GC IRRIGATOR
K980868 · KPL
Gentle Colonics, Inc.
Gastroenterology & Urology · 153d
Cleared Aug 06, 1998
TOXOGEN
K981263 · GMM
Instrumentation Laboratory CO
Microbiology · 121d
Cleared Aug 06, 1998
DBEST AMPHETAMINES TEST KIT
K981504 · DKZ
Ameritek, Inc.
Toxicology · 101d
Cleared Aug 06, 1998
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K981684 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 85d
Cleared Aug 06, 1998
BISSINGER CABLES, CAT. NO. 801000XX
K981919 · GEI
Guenter Bissinger Medizintechnik GmbH
General & Plastic Surgery · 66d