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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
146569–146592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 1985
POLYGEL ULTRASOUND GEL
K851895 · IYO
Parker Laboratories, Inc.
Radiology · 150d
Cleared Sep 27, 1985
MODEL U-1000 ULTRASONIC SCANNER
K851902 · HEM
Fukuda Denshi USA, Inc.
Obstetrics & Gynecology · 150d
Cleared Sep 27, 1985
ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81
K852113 · FLE
Ars Enterprises, Inc.
General Hospital · 135d
Cleared Sep 27, 1985
ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000
K852114 · FLE
Ars Enterprises, Inc.
General Hospital · 135d
Cleared Sep 27, 1985
MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET
K852194 · LHD
Sharp Electronics Corp.
Obstetrics & Gynecology · 130d
Cleared Sep 27, 1985
SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM
K852608 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 100d
Cleared Sep 27, 1985
ODONTO TOOTHBRUSH
K852691 · EFW
Action Hygiene Products, Inc.
Dental · 93d
Cleared Sep 27, 1985
WUNDERSHADE
K852868 · EBF
Harry J. Bosworth Co.
Dental · 81d
Cleared Sep 27, 1985
RHINOTEST MP
K853024 · BXQ
Intertronic, Inc.
Anesthesiology · 71d
Cleared Sep 27, 1985
FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10
K853320 · ETW
Rastronics USA, Inc.
Ear, Nose, Throat · 59d
Cleared Sep 27, 1985
INTRA VAGINAL TRANSDUCER
K853407 · HEM
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 46d
Cleared Sep 27, 1985
PERFECT 10
K853498 · EJH
North American Alloys, Inc.
Dental · 38d
Cleared Sep 26, 1985
ADENOVIRUS
K843649 · GOD
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
CYTOMEGALOVIRUS
K843657 · GQH
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
H. SIMPLEX VIRUS
K843658 · GQN
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
INFLUENZA A2 VIRUS
K843659 · GNX
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
IN FLUENZA B VIRUS
K843660 · GNX
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
MEASLES VIRUS RUBEOLA
K843662 · GRJ
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
PARAINFLUENZA 1
K843665 · GQS
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
PARAINFLUENZA 3
K843667 · GQS
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
RESPIRATORY SYNCYTIAL VIRUS
K843673 · GQG
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
VARICELLA/ZOSTER VIRUS
K843676 · GQW
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
TRAUMA CARE EVALUATION
K843905 · PLB
Quantitative
General Hospital · 358d
Cleared Sep 26, 1985
CLINICOMP RDMS RADIONUCLIDE DISPENSING MGMT. SOFTW
K850838 · KPT
Clinicomp, Inc.
Radiology · 209d