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
86329–86352 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1999
PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)
K982600 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 228d
Cleared Mar 12, 1999
GYNEX ELECTRODES
K982739 · HGI
Gynex Corp.
Obstetrics & Gynecology · 218d
Cleared Mar 12, 1999
SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR
K983355 · FLL
Sabratek Corp.
General Hospital · 170d
Cleared Mar 12, 1999
BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B
K983843 · MAI
Arthrex, Inc.
Orthopedic · 133d
Cleared Mar 12, 1999
RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)
K983918 · IXA
Mastek, Inc.
Radiology · 128d
Cleared Mar 12, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC...
K984289 · LTJ
Ortho-Clinical Diagnostics, Inc.
Immunology · 101d
Cleared Mar 12, 1999
SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
K984518 · ESD
Sonic Innovations, Inc.
Ear, Nose, Throat · 81d
Cleared Mar 12, 1999
BIOSACA SYSTEM
K984580 · OLV
Biosys AB (Publ)
Neurology · 79d
Cleared Mar 12, 1999
3D-ANGIO
K984634 · JAK
Siemens Medical Corp.
Radiology · 72d
Cleared Mar 12, 1999
CD-DENT DIGITAL IMAGING DEVICES FOR DENTAL X-RAY SYSTEMS, MODELS 600, 1000...
K990049 · MUH
Digident , Ltd.
Radiology · 64d
Cleared Mar 12, 1999
BIOPSY-DIGIT
K990192 · IZH
Sitco, Inc.
Radiology · 50d
Cleared Mar 12, 1999
SYNERGY CEMENTED HIP STEM
K990369 · JDI
Smith & Nephew, Inc.
Orthopedic · 32d
Cleared Mar 12, 1999
ULTRACISION HARMONIC SCALPEL HAND PIECE
K990430 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 29d
Cleared Mar 12, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS
K990531 · JJY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 21d
Cleared Mar 11, 1999
BUZBEE
K982173 · GZJ
Mwr Electronics Industrial Co.
Neurology · 265d
Cleared Mar 11, 1999
ZOLL M SERIES SPO2 OPTION
K982992 · MKJ
Zoll Medical Corp
Cardiovascular · 196d
Cleared Mar 11, 1999
CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM
K983171 · MTD
Boston Scientific Corp
Cardiovascular · 182d
Cleared Mar 11, 1999
GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
K983927 · DQT
Arterial Vascular Engineering, Inc.
Cardiovascular · 126d
Cleared Mar 11, 1999
UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET
K984418 · DXT
Medrad, Inc.
Cardiovascular · 91d
Cleared Mar 11, 1999
ELECTROGLOTTOGRAPH
K990240 · KLX
Kay Elemetrics Corp.
Ear, Nose, Throat · 45d
Cleared Mar 11, 1999
MABIS NB-02 ULTRASONIC NEBULIZER
K990506 · CAF
Mabis Healthcare, Inc.
Anesthesiology · 22d
Cleared Mar 11, 1999
ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA
K990573 · DXC
Estech, Inc.
Cardiovascular · 16d
Cleared Mar 10, 1999
TITANIUM FEMORAL COMPONENT
K981996 · JWH
Biomet, Inc.
Orthopedic · 275d
Cleared Mar 10, 1999
MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K990603 · KWQ
Danek Medical, Inc.
Orthopedic · 15d