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
117433–117456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 1992
BIOTRACK CARBAMAZEPINE TEST CARTRIDGE
K915756 · KLT
Biotrack, Inc.
Toxicology · 213d
Cleared Jul 23, 1992
LATEX EXAM/SURGICAL GLOVES
K920202 · LYY
Redsun Latex , Ltd.
General Hospital · 190d
Cleared Jul 23, 1992
MAX-E-VAC
K920217 · GEI
Leisegang Medical, Inc.
General & Plastic Surgery · 189d
Cleared Jul 23, 1992
MERKUR 4000
K920575 · FAP
F.M. Wiest USA, Inc.
Gastroenterology & Urology · 167d
Cleared Jul 23, 1992
COMPASEP
K920649 · FMC
Wilde-USA, Inc.
General Hospital · 162d
Cleared Jul 23, 1992
IL TEST BILIRUBIN TOTAL/DIRECT
K920653 · CIG
Instrumentation Laboratory CO
Chemistry · 162d
Cleared Jul 23, 1992
DEROYAL TRANSPARENT FILM DRESSIGN
K920796 · MGP
Deroyal Industries, Inc.
General & Plastic Surgery · 153d
Cleared Jul 23, 1992
NASAL SEPTAL SPLINT
K921195 · LYA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 133d
Cleared Jul 23, 1992
TURBINATE NASAL SPLINT
K921202 · LYA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 133d
Cleared Jul 23, 1992
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE
K921435 · LQF
Gen-Probe, Inc.
Microbiology · 120d
Cleared Jul 23, 1992
CURASOL(TM) WOUND DRESSING
K921810 · MGQ
Healthsouth Medical Center
General & Plastic Surgery · 99d
Cleared Jul 23, 1992
CUFF-M
K921997 · DXQ
Lorin Medical, Inc.
Cardiovascular · 86d
Cleared Jul 23, 1992
REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175
K922024 · CEF
Helena Laboratories
Chemistry · 83d
Cleared Jul 23, 1992
OSTEO KIRSCHNER WIRE
K922193 · HTY
Osteo AG
Orthopedic · 73d
Cleared Jul 23, 1992
OSTEO STEINMANN PIN
K922194 · HTY
Osteo AG
Orthopedic · 73d
Cleared Jul 23, 1992
OSTEO FEMORAL NAIL
K922195 · HSB
Osteo AG
Orthopedic · 73d
Cleared Jul 23, 1992
OSTEO TIBIA NAIL
K922196 · HSB
Osteo AG
Orthopedic · 73d
Cleared Jul 23, 1992
SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOL
K922410 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 63d
Cleared Jul 23, 1992
VLC DYCAL II
K922721 · EJK
Dentsply Intl.
Dental · 48d
Cleared Jul 23, 1992
CLOSED CHAIN ATTACHMENT, MODEL #820-520
K923350 · IKK
Biodan Medical Systems, Ltd.
Physical Medicine · 15d
Cleared Jul 22, 1992
ABBOTT STREP A CONTROLS
K922490 · GTY
Abbott Laboratories
Microbiology · 56d
Cleared Jul 21, 1992
LATEX PROPHYLACTIC (CONDOM)
K912405 · HIS
Hevealactics Intl. Sdn Bhd
Obstetrics & Gynecology · 418d
Cleared Jul 21, 1992
COHERENT VERSAPULSE(TM) 2.1XE/2.1L HOLMI SURG LASE
K914136 · GEX
Coherent Medical Group
General & Plastic Surgery · 309d
Cleared Jul 21, 1992
EXCEL CT TWIN
K915738 · JAK
Elscint, Inc.
Radiology · 214d