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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
123481–123504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 1990
MENTOR TISSUE EXPANDERS W/TDMAC COATING
K894475 · LCJ
Mentor Corp.
General & Plastic Surgery · 496d
Cleared Nov 26, 1990
ACE/WILLIAMS MICROSURGERY SAW SYSTEM
K902525 · HWE
Buckman Co., Inc.
Orthopedic · 174d
Cleared Nov 26, 1990
COLOR VELOCITY IMAGING (CVI) OPTION FOR PLATINUM
K902926 · ITX
Philips Medical Systems North...
Radiology · 146d
Cleared Nov 26, 1990
A-1103 ABUTMENT (REMOVABLE)
K903040 · DZE
Minimatic Implant Technology
Dental · 138d
Cleared Nov 26, 1990
MUSCLE MASSAGER
K903617 · ISA
Uri Halfon and Gabriel Hertzberg
Physical Medicine · 110d
Cleared Nov 26, 1990
VSP HIP STEM
K903957 · JDI
Turnkey Intergration USA, Inc.
Orthopedic · 90d
Cleared Nov 26, 1990
CUI FEATHERED SILICONE MALAR
K904348 · LZK
Cui Corp.
General & Plastic Surgery · 63d
Cleared Nov 26, 1990
CUI CURVILINEAR SILICONE CHIN
K904349 · FWP
Cui Corp.
General & Plastic Surgery · 63d
Cleared Nov 26, 1990
CUI DORSAL COLUMELLA PROSTHESIS
K904350 · FZE
Cui Corp.
General & Plastic Surgery · 63d
Cleared Nov 26, 1990
KIMONO PLUS
K904375 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 62d
Cleared Nov 26, 1990
INTRASITE GEL (LABELING REVISION)
K904411 · KMF
Smith & Nephew United, Inc.
General & Plastic Surgery · 61d
Cleared Nov 26, 1990
VARIOUS MODELS OF WHEELCHAIRS
K904522 · INI
Hadco Marketing Services, Inc.
Physical Medicine · 55d
Cleared Nov 26, 1990
MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T
K904796 · ILQ
Personal Emergency Response System
Physical Medicine · 34d
Cleared Nov 26, 1990
A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS
K904949 · HSZ
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 24d
Cleared Nov 26, 1990
MANUAL AND MOTORIZED FLEXION DISTRACTION TABLES
K904950 · INQ
Leander Research, Mfg & Distr., Inc.
Physical Medicine · 24d
Cleared Nov 26, 1990
TEMPEST ELECTRIC WHEELCHAIR
K904958 · ITI
Everest & Jennings, Inc.
Physical Medicine · 21d
Cleared Nov 26, 1990
STAGE ZERO AIR FLOTATION BED
K905053 · IOQ
Lake Medical Products, Inc.
Physical Medicine · 18d
Cleared Nov 26, 1990
ROTO REST
K905113 · IKZ
Ethos Medical Products , Ltd.
Physical Medicine · 13d
Cleared Nov 23, 1990
MAC LAVE STEAM STERILIZER
K895275 · FLE
Merchants Export Development Corp.
General Hospital · 457d
Cleared Nov 23, 1990
CEPHALIC DOPPLER W/ULTRAMARK 9 ULTRASOUND SYSTEM
K901329 · IYN
Advanced Technology Laboratories, Inc.
Radiology · 247d
Cleared Nov 23, 1990
MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE
K901654 · IXR
Imt America, Inc.
Radiology · 227d
Cleared Nov 23, 1990
NORLAND XR26 LATERAL SPINE OPTION
K902959 · KGI
Norland Corp.
Radiology · 141d
Cleared Nov 23, 1990
CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER
K903154 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 128d
Cleared Nov 23, 1990
CANNULA, SURGICAL
K903416 · GEA
Advantage Diagnostics Corp.
General & Plastic Surgery · 116d