FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76273–76296 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 2002
SIMIDUR S2
K020192 · EJS
Wieland Dental + Technik GmbH & Co. KG
Dental · 52d
Cleared Mar 15, 2002
SIMIDUR KF PLUS
K020194 · EJS
Wieland Dental + Technik GmbH & Co. KG
Dental · 52d
Cleared Mar 15, 2002
SIMIDUR S1S
K020195 · EJS
Wieland Dental + Technik GmbH & Co. KG
Dental · 52d
Cleared Mar 15, 2002
ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY
K020217 · JJX
Bayer Diagnostics Corp.
Chemistry · 52d
Cleared Mar 15, 2002
CLASSIC TENS
K020437 · GZJ
Care Rehab, Inc.
Neurology · 35d
Cleared Mar 15, 2002
GAZELLE WHEELCHAIR
K020536 · IOR
Alum Creek Wheelchair Co., Inc.
Physical Medicine · 24d
Cleared Mar 15, 2002
ENGUARD REMOTE PATIENT MONITOR
K020632 · QYX
Mennen Medical , Ltd.
Cardiovascular · 16d
Cleared Mar 15, 2002
MODIFICATION TO THE MAESTRO SYSTEM
K020645 · DZE
BioHorizons Implant Systems, Inc.
Dental · 15d
Cleared Mar 14, 2002
MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL
K012350 · FWP
Porex Surgical, Inc.
General & Plastic Surgery · 232d
Cleared Mar 14, 2002
VECTORVISION TRAUMA
K012448 · HAW
Brainlab AG
Neurology · 225d
Cleared Mar 14, 2002
AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000
K012796 · DXN
Amluck, Inc.
Cardiovascular · 205d
Cleared Mar 14, 2002
EMS HEPA FILTER AND HME COMBINATIONS
K013089 · CAH
Engineered Medical Systems
General Hospital · 178d
Cleared Mar 14, 2002
EMS PULMONARY FUNCTION TESTING FILTER
K013123 · BZG
Engineered Medical Systems
Anesthesiology · 176d
Cleared Mar 14, 2002
MITEK BIOCRYL INTERFERENCE SCREWS
K013572 · HWC
Mitek Products
Orthopedic · 136d
Cleared Mar 14, 2002
PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE
K014133 · DYH
Pulpdent Corp.
Dental · 87d
Cleared Mar 14, 2002
PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT
K014138 · DYH
Pulpdent Corp.
Dental · 87d
Cleared Mar 14, 2002
ENDOSCOPIC CAMERA TC804/C4
K014158 · GCJ
World of Medicine Lemke GmbH
General & Plastic Surgery · 85d
Cleared Mar 14, 2002
IALUSET HYDROCOLLOID
K020041 · FRO
Institut Biochimique SA (Ibsa)
General & Plastic Surgery · 66d
Cleared Mar 14, 2002
MICROSCAN SYNERGIES PLUS
K020142 · LON
Dade Behring, Inc.
Microbiology · 57d
Cleared Mar 14, 2002
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN
K020160 · LTT
Dade Behring, Inc.
Microbiology · 56d
Cleared Mar 14, 2002
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN
K020162 · JWY
Dade Behring, Inc.
Microbiology · 56d
Cleared Mar 14, 2002
CHASE CARDIOVASCULAR PATCH KIT
K020233 · DXZ
Chase Medical, Inc.
Cardiovascular · 50d
Cleared Mar 14, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH...
K020248 · LON
Dade Behring, Inc.
Microbiology · 49d
Cleared Mar 14, 2002
SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA
K020270 · GCJ
Sopro
General & Plastic Surgery · 45d