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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
75769–75792 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 14, 2002
ENDOSCOPIC CAMERA MC404/C3
K020336 · GCJ
World of Medicine Lemke GmbH
General & Plastic Surgery · 41d
Cleared Mar 14, 2002
COMFORT WHEELCHAIRS
K020451 · IOR
Comfort Orthopedic Co., Ltd.
Physical Medicine · 31d
Cleared Mar 13, 2002
AUTOMARQER
K012805 · POV
Hamilton Thorne Research
Hematology · 204d
Cleared Mar 13, 2002
ACIST 4 FRENCH ANGIOGRAPHIC CATHETER
K012983 · DQO
Acist Medical Systems, Inc.
Cardiovascular · 189d
Cleared Mar 13, 2002
AMPHETAMINE/METHAMPHETAMINE
K012998 · LAF
Abbott Laboratories
Toxicology · 188d
Cleared Mar 13, 2002
COCAINE
K013004 · DIO
Abbott Laboratories
Toxicology · 188d
Cleared Mar 13, 2002
PHENCYCLIDINE
K013096 · LCM
Abbott Laboratories
Toxicology · 177d
Cleared Mar 13, 2002
BENZODIAZEPINES
K013143 · JXM
Abbott Laboratories
Toxicology · 174d
Cleared Mar 13, 2002
CANNABINOIDS
K013247 · LDJ
Abbott Laboratories
Toxicology · 166d