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
147745–147768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 1985
EMIT IMIPRAMINE ASSAY
K844951 · LFG
Syva Co.
Toxicology · 190d
Cleared Jun 28, 1985
EMIT NORTRIPTYLINE ASSAY
K844952 · LFG
Syva Co.
Toxicology · 190d
Cleared Jun 28, 1985
EMIT DESIPRAMINE ASSAY
K844953 · LFG
Syva Co.
Toxicology · 190d
Cleared Jun 28, 1985
SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS
K850634 · GCY
Surgidyne, Inc.
General & Plastic Surgery · 129d
Cleared Jun 28, 1985
FLUTED SUCTION MENISCAL CUTTER
K850789 · KIJ
T. Korossurgical Instruments Corp.
Orthopedic · 122d
Cleared Jun 28, 1985
UNIVERSAL POWER FLEX
K851177 · BXB
Biodynamic Technologies, Inc.
Physical Medicine · 95d
Cleared Jun 28, 1985
MOBIE SCOOTER
K851256 · INI
Everest & Jennings, Inc.
Physical Medicine · 92d
Cleared Jun 28, 1985
CRS ULTRALITE PREMIER
K851257 · IOR
Everest & Jennings, Inc.
Physical Medicine · 92d
Cleared Jun 28, 1985
AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE
K851374 · HRX
American Edwards Laboratories
Orthopedic · 81d
Cleared Jun 28, 1985
SEGMENTAL SPINAL RODS
K851414 · KWQ
Stuart
Orthopedic · 80d
Cleared Jun 28, 1985
SAFESTRETCH INCONTINENCE SYSTEM
K851681 · KNX
Dbt Medical , Ltd.
Gastroenterology & Urology · 66d
Cleared Jun 28, 1985
SUPRACONDYLAR BONE PLATE
K851919 · KTT
Warsaw Orthopedic, Inc.
Orthopedic · 57d
Cleared Jun 28, 1985
OMNIMED SURGICAL GOWN
K851938 · FYA
Omni Intl., Inc.
General Hospital · 56d
Cleared Jun 28, 1985
ECHOCLONAL HCG IRMA
K852201 · JHI
Bio-Rad
Chemistry · 38d
Cleared Jun 28, 1985
ANSWER
K852274 · LCX
Armkel, LLC
Chemistry · 30d
Cleared Jun 28, 1985
BTM TOTAL HIP SYSTEM
K852420 · KWL
Kirschner Medical Corp.
Orthopedic · 21d
Cleared Jun 28, 1985
WEITIANER MASTOID 3 VS 4 BLUNT & SHARP PRONGS
K852530 · GAD
The Huxley Instrument Corp.
General & Plastic Surgery · 14d
Cleared Jun 28, 1985
NON-PERFORATING TOWEL FORCEPS-5-1/4 IN SS 410
K852531 · GEN
The Huxley Instrument Corp.
General & Plastic Surgery · 14d
Cleared Jun 28, 1985
SPLINTREX
K852555
Allison Forge Corp.
General & Plastic Surgery · 11d
Cleared Jun 28, 1985
PINSET, BONE, RUSH 9-1/2 THRU 20-3/4 INCHES LONG
K852560 · HTY
The Huxley Instrument Corp.
Orthopedic · 11d
Cleared Jun 28, 1985
PIN SET, BONEM, RUSH, 1 THRU 10 INCHES LONG
K852561 · HTY
The Huxley Instrument Corp.
Orthopedic · 11d
Cleared Jun 28, 1985
PIN SET, BONE, RUSH, 4 THRU 10 1/2 INCHES LONG
K852562 · HTY
The Huxley Instrument Corp.
Orthopedic · 11d
Cleared Jun 28, 1985
PIN SET, BONE RUSH, 7-1/4 THRU 18-1/2 INCHES LONG
K852563 · HTY
The Huxley Instrument Corp.
Orthopedic · 11d
Cleared Jun 27, 1985
CONTINUOUS VENTILATOR
K844809 · GBX
Hamilton Medical, Inc.
General & Plastic Surgery · 182d