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
118825–118848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1991
DEPUY (NITINO) GUIDE WIRE
K914693 · JDQ
Depuy, Inc.
Orthopedic · 52d
Cleared Dec 09, 1991
F383 RECHARGEABLE MINI MASSAGER
K914703 · IRO
Fairform Mfg., Co., Ltd.
Physical Medicine · 52d
Cleared Dec 09, 1991
FO69 FANCY MASSAGER
K914704 · IRO
Fairform Mfg., Co., Ltd.
Physical Medicine · 52d
Cleared Dec 09, 1991
FO41 BODY MASSAGER
K914705 · IRO
Fairform Mfg., Co., Ltd.
Physical Medicine · 52d
Cleared Dec 09, 1991
FO51/F151 GOLF MASSAGER
K914706 · IRO
Fairform Mfg., Co., Ltd.
Physical Medicine · 52d
Cleared Dec 09, 1991
F055 B.O. FANTASTIC RELAXER
K914707 · IRO
Fairform Mfg., Co., Ltd.
Physical Medicine · 52d
Cleared Dec 09, 1991
SUCTION/IRRIGATION KITTNER
K914781 · GCJ
O.R. Concepts, Inc.
General & Plastic Surgery · 47d
Cleared Dec 09, 1991
SUCTION/IRRIGATION PROBE
K914782 · GCJ
O.R. Concepts, Inc.
General & Plastic Surgery · 47d
Cleared Dec 09, 1991
IMMUNOWELL DSDNA ANTIBODY TEST
K914801 · DHC
General Biometrics, Inc.
Immunology · 46d
Cleared Dec 09, 1991
FO92 SEATING MASSAGER
K914829 · IRO
Fairform Mfg., Co., Ltd.
Physical Medicine · 45d
Cleared Dec 09, 1991
A101 LITESSAGER
K914830 · IRO
Fairform Mfg., Co., Ltd.
Physical Medicine · 45d
Cleared Dec 09, 1991
CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE
K914850 · DHB
Mast Immunosystems
Immunology · 42d
Cleared Dec 09, 1991
PHENCYCLIDINE EIA ASSAY
K915179 · LCM
Diagnostic Reagents, Inc.
Toxicology · 24d
Cleared Dec 09, 1991
CEDIA T4
K915194 · KLI
Boehringer Mannheim Corp.
Chemistry · 20d
Cleared Dec 06, 1991
SCHNEIDER SOFTIP(R) A+(TM) ANGIOGRAPHIC CATHETER
K914009 · DQO
Schneider Intl., Ltd.
Cardiovascular · 88d
Cleared Dec 06, 1991
NK PINCH SENSOR, MODEL PA002
K914058 · LBB
Nk Biotechnical Engineering Co.
Neurology · 87d
Cleared Dec 06, 1991
SHARPLAN SHARPLASE FAMILY OF HANDSWITCHED ND:YAG
K914089 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 86d
Cleared Dec 05, 1991
SYSTEM ATHENA - PRODUCT ENHANCEMENTS
K912049 · DRT
S & W Medico Teknik
Cardiovascular · 240d
Cleared Dec 05, 1991
BIOPSY ACCESSORIES FOR ULTRASOUND PROBES
K912088 · ITX
Biosound, Inc.
Radiology · 206d
Cleared Dec 05, 1991
REMOVE LABELING RESTRICT FROM GUIDE WIRES
K912293 · DQX
Target Therapeutics
Cardiovascular · 196d
Cleared Dec 05, 1991
THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER
K913356 · EWO
Monitor Instruments, Inc.
Ear, Nose, Throat · 128d
Cleared Dec 05, 1991
ALPHATEC CANNULATED BONE SCREWS
K914004 · HWC
Alphatec Mfg., Inc.
Orthopedic · 90d
Cleared Dec 05, 1991
ZARA ZONE IV MALAR IMPLANT
K914016 · LZK
Byron Medical
General & Plastic Surgery · 87d
Cleared Dec 05, 1991
KINAMED CTN STEM
K914237 · LZO
Kinamed, Inc.
Orthopedic · 76d