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
76297–76320 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 13, 2002
OPIATES
K013314 · DJG
Abbott Laboratories
Toxicology · 160d
Cleared Mar 13, 2002
IMUBIND TPA ELISA, MODEL 860
K013492 · GGP
American Diagnostica, Inc.
Hematology · 142d
Cleared Mar 13, 2002
STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50...
K014230 · KGO
Supermax Glove Manufacturing Sdn Bhd
General Hospital · 77d
Cleared Mar 13, 2002
IMPLANT GUIDANCE SYSTEM APPLICATOR SET
K020015 · JAQ
Nucletron Corp.
Radiology · 69d
Cleared Mar 13, 2002
PISCES PLUS (DW286 C)
K020183 · EJH
Ivoclar Vivadent, Inc.
Dental · 54d
Cleared Mar 13, 2002
PORTADUR P 4
K020190 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 50d
Cleared Mar 13, 2002
PLAYTEX DEODORANT TAMPONS, MODEL 34802
K020200 · HIL
Playtex Products, Inc.
Obstetrics & Gynecology · 50d
Cleared Mar 13, 2002
QACA IGG/IGM ELISA KIT
K020241 · MID
Cheshire Diagnostics , Ltd.
Immunology · 49d
Cleared Mar 13, 2002
LIFESTYLE OXYGEN CONCENTRATOR
K020324 · CAW
Airsep Corp.
Anesthesiology · 41d
Cleared Mar 13, 2002
MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K020446 · HWC
American Medical Systems, Inc.
General & Plastic Surgery · 30d
Cleared Mar 13, 2002
MODIFICATION TO MAGNETOM RHAPSODY SYSTEM
K020573 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 44d
Cleared Mar 13, 2002
MTP CLEARVISION DISPOSABLE TUBING SET
K020599 · EOB
Mtp Medical Technical Promotion GmbH
Ear, Nose, Throat · 19d
Cleared Mar 13, 2002
NVA-63-8 NEUROVASCULAR ARRAY COIL
K020606 · MOS
Mri Devices Corp.
Radiology · 16d
Cleared Mar 12, 2002
HIGHGATE CURVED ROD SYSTEM
K012045 · KWQ
Highgate Orthopaedics
Orthopedic · 256d
Cleared Mar 12, 2002
PREFERNCE IMRT TREATMENT PLANNING MODULE
K012575 · MUJ
Northwest Medical Physics Equipment,...
Radiology · 215d