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
89761–89784 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1998
FETAL D TECTION KIT
K980314 · LIM
Biopool Intl., Inc.
Hematology · 71d
Cleared Apr 08, 1998
COLOURED POWDWR-FREE SURGICAL GLOVES
K980412 · KGO
Kenwell International , Ltd.
General Hospital · 64d
Cleared Apr 08, 1998
URESIL NEPHRO-URETERAL STENT
K980889 · LJE
Uresil Corp.
Gastroenterology & Urology · 30d
Cleared Apr 07, 1998
KEELER TEARSCOPE-PLUS
K973064 · HJO
Keeler Instruments, Inc.
Ophthalmic · 232d
Cleared Apr 07, 1998
HORTMANN AMDIS-OAE OAE ANALYZER
K980505 · EWO
Hortmann AG
Ear, Nose, Throat · 57d
Cleared Apr 07, 1998
ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT...
K980554 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 53d
Cleared Apr 07, 1998
NEVA SYSTEM
K980627 · LIL
Urometrics, Inc.
Gastroenterology & Urology · 48d
Cleared Apr 06, 1998
MANAN POTTS-COURNAND NEEDLE
K974742 · DRC
Medical Device Technologies, Inc.
Cardiovascular · 108d
Cleared Apr 06, 1998
MANAN
K974743 · DRC
Medical Device Technologies, Inc.
Cardiovascular · 108d
Cleared Apr 06, 1998
MANAN GWI GUIDE WIRE INTRODUCER
K974745 · DRC
Medical Device Technologies, Inc.
Cardiovascular · 108d
Cleared Apr 06, 1998
RELEASABLE FORCE MODULE
K980151 · DZB
Ortho Kinetics Corp.
Dental · 80d
Cleared Apr 06, 1998
IV STANDS
K980336 · FOX
Clinton Industries, Inc.
General Hospital · 68d
Cleared Apr 06, 1998
KHT SOFT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE
K980470 · MQX
American Institute of Koryo Hand Therapy
General Hospital · 59d
Cleared Apr 06, 1998
LYPHOCHEK WHOLE BLOOD CONTROL
K980871 · DIF
Bio-Rad
Toxicology · 46d
Cleared Apr 03, 1998
THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER
K972824 · BWF
Pn Medical
Anesthesiology · 247d
Cleared Apr 03, 1998
OZ POWER SYRINGE
K973334 · DXT
Cardiovascular Innovations
Cardiovascular · 211d
Cleared Apr 03, 1998
PROFUSION BONE VOID FILLER
K973704 · MQV
Biogeneration
Orthopedic · 186d
Cleared Apr 03, 1998
REJUVENESS
K974380 · MDA
Rejuveness Pharamceuticals, Inc.
General & Plastic Surgery · 164d
Cleared Apr 03, 1998
ACTIVELOCK MODULAR FEMORAL HIP SYSTEM
K980020 · LPH
Metagen, LLC
Orthopedic · 88d
Cleared Apr 03, 1998
XENON 300MX
K980044 · FSS
Perkinelmer Optoelectronics
General & Plastic Surgery · 87d
Cleared Apr 03, 1998
BTI HUMERAL INTRAMEDULLARY ROD SYSTEM
K980102 · HSB
Biodynamic Technologies, Inc.
Orthopedic · 81d
Cleared Apr 03, 1998
WALLSTENT ENTERAL ENDOPROSTHESIS
K980113 · MUM
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 80d
Cleared Apr 03, 1998
SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT
K980138 · FWP
Spectrum Designs, Inc.
General & Plastic Surgery · 78d
Cleared Apr 03, 1998
FEATHERLITE DIODE LASER
K980142 · GEX
Laserlite, LLC
General & Plastic Surgery · 78d