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
122089–122112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 1991
VISION BG MONITOR
K911596 · CGA
British-American Medical, Inc.
Chemistry · 36d
Cleared May 15, 1991
MIRCOLINE SCREEN FOR COCAINE
K911652 · DIO
Drug Screening Systems, Inc.
Toxicology · 33d
Cleared May 15, 1991
G-FLOSS & G-FLOSS II
K911701 · JES
Implant Innovations International, Inc.
Dental · 29d
Cleared May 15, 1991
STRATUS(R) AUTOMATED SAMPLE HANDLER
K911712 · JQW
Baxter Healthcare Corp
Chemistry · 28d
Cleared May 15, 1991
FIRST CHOICE(TM), MODIFICATION
K911792 · CGA
Polymer Technology Corp.
Chemistry · 23d
Cleared May 15, 1991
HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED
K911803 · JJY
Hichem Diagnostics
Chemistry · 22d
Cleared May 15, 1991
CEDIA(R) DIGOXIN R' ASSAY
K911941 · KXT
Microgenics Corp.
Toxicology · 14d
Cleared May 14, 1991
DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2)
K902607 · GWF
Dantec Medical, Inc.
Neurology · 336d
Cleared May 14, 1991
TENS CONDUCTIVE MEDIA PAD
K904889 · GYB
Creative Design Systems, Inc.
Neurology · 204d
Cleared May 14, 1991
PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM
K905397 · CCE
Puritan Bennett Corp.
Anesthesiology · 165d
Cleared May 14, 1991
SPARK KIT(R), MODIFICATION
K910142 · FPA
Lyphomed, Inc.
General Hospital · 120d
Cleared May 14, 1991
PATHFINDER
K910601 · HPG
Nurion Industries
Ophthalmic · 90d
Cleared May 14, 1991
AP-860PA NIBP MODULE
K910629 · DQA
Nihon Kohden America, Inc.
Anesthesiology · 90d
Cleared May 14, 1991
504US PULSE OXIMETER
K910770 · DQA
Criticare Systems, Inc.
Anesthesiology · 81d
Cleared May 13, 1991
MODIFIED AEROCHAMBER WITH MASK
K900576 · CCQ
Monaghan Medical Corp.
Anesthesiology · 460d
Cleared May 13, 1991
MENS-O-MATIC I
K904234 · GZJ
Monad Corp.
Neurology · 248d
Cleared May 13, 1991
MENS-O-MATIC 2000
K904235 · GZJ
Monad Corp.
Neurology · 250d
Cleared May 13, 1991
MICRO DERM
K904258 · GZJ
Monad Corp.
Neurology · 241d
Cleared May 13, 1991
MENS-O-MATIC 3000
K904260 · GZJ
Monad Corp.
Neurology · 241d
Cleared May 13, 1991
MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS
K904288 · GZJ
Monad Corp.
Neurology · 236d
Cleared May 13, 1991
MENS FREEDOM MICRO
K904430 · GZJ
Monad Corp.
Neurology · 250d
Cleared May 13, 1991
MEDTRONIC SULLIVAN NASAL CPAP SYSTEM
K905404 · BZD
Medtronic Vascular
Anesthesiology · 161d
Cleared May 13, 1991
COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM
K910194 · BZD
Puritan Bennett Corp.
Anesthesiology · 117d
Cleared May 13, 1991
INTRAVASCULAR IMAGING SYSTEM/MODIFIED
K910281 · JOP
Intertherapy, Inc.
Cardiovascular · 110d