FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
124081–124104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 23, 1990
ANGIOTEC IMAGE MANAGEMENT SYSTEM
K903806 · LMB
Andros Analyzers, Inc.
Radiology · 95d
Cleared Nov 23, 1990
NEONATAL METASCOPE
K903959 · BZK
Cybermedic, Inc.
Anesthesiology · 87d
Cleared Nov 23, 1990
HTR POLYMER, HTR-MX
K904111 · KKY
United States Surgical, A Division of...
General & Plastic Surgery · 78d
Cleared Nov 23, 1990
DUAL LUMEN NEEDLES
K904433 · LBW
Akcess Medical Products, Inc.
Gastroenterology & Urology · 56d
Cleared Nov 23, 1990
LABELLING MODIFICATION TO MAXX PLUS
K904453 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 57d
Cleared Nov 23, 1990
HYPOALLERGENIC CRANBERRY/MALAYTEX LATEX EXAM GLOVE
K904526 · LYY
Malaytex USA, Inc.
General Hospital · 53d
Cleared Nov 21, 1990
BIOCLUSIVE(R) ABSORBENT DRESSING
K896828 · KOZ
Johnson & Johnson International
General & Plastic Surgery · 352d
Cleared Nov 21, 1990
PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES
K900295 · KDJ
Microwave Medical Systems, Inc.
Gastroenterology & Urology · 303d
Cleared Nov 21, 1990
FOLEY CATHETER
K902710 · EZL
Societa Gruppi Elastomeri S.A.
Gastroenterology & Urology · 154d
Cleared Nov 21, 1990
VERIFUSE AMBULATORY PUMP
K902891 · FRN
Block Medical, Inc.
General Hospital · 142d