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
75793–75816 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 12, 2002
SONOPSY
K013109 · FCG
Hakko Medical Co., Ltd.
Gastroenterology & Urology · 176d
Cleared Mar 12, 2002
IN-TIME RETRIEVAL DEVICE
K014109 · MMX
Boston Scientific, Target
Cardiovascular · 88d
Cleared Mar 12, 2002
GREAT TOE IMPLANT SYSTEM
K014164 · KWD
Harmos Orthopaedics, Inc.
Orthopedic · 83d
Cleared Mar 12, 2002
PLAYTEX DEODORANT TAMPONS, MODEL 34902
K020201 · HIL
Playtex Products, Inc.
Obstetrics & Gynecology · 49d
Cleared Mar 12, 2002
PLAYTEX DEODORANT TAMPONS, MODEL 34702
K020202 · HIL
Playtex Products, Inc.
Obstetrics & Gynecology · 49d
Cleared Mar 12, 2002
NUVASIVE TRIAD FACET SCREW SYSTEM
K020411 · MRW
Nuvasive, Inc.
Orthopedic · 33d
Cleared Mar 12, 2002
RBM
K020480 · KGS
Smith & Nephew, Inc.
General & Plastic Surgery · 27d
Cleared Mar 12, 2002
ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML
K020485 · KPE
Baxter Healthcare Corp
General Hospital · 27d
Cleared Mar 12, 2002
WING SAFE INFUSION SET 20 GA, SHS2000 SERIES
K020544 · FPA
Churchill Medical Systems, Inc.
General Hospital · 25d