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
112945–112968 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 1993
CONE CATH
K931156 · EXJ
Sierra Laboratories, Inc.
Gastroenterology & Urology · 114d
Cleared Jul 01, 1993
CM7000 REMOTE INDICATOR
K931287 · CAP
Canadian Monaghan , Ltd.
Anesthesiology · 111d
Cleared Jul 01, 1993
GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR
K931340 · GCS
Baxter Healthcare Corp
Gastroenterology & Urology · 107d
Cleared Jul 01, 1993
CM5000R REMOTE INDICATOR
K931394 · CAP
Canadian Monaghan , Ltd.
Anesthesiology · 104d
Cleared Jul 01, 1993
SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS.
K931584 · DQX
Scimed
Cardiovascular · 92d
Cleared Jun 29, 1993
BHR BIPOLAR FEMORAL HEAD COMPONENT
K915528 · LZY
Implantology Corp.
Orthopedic · 567d
Cleared Jun 29, 1993
MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA
K915633 · FLL
S & W Medico Teknik
General Hospital · 609d
Cleared Jun 29, 1993
ZEPHYR INFUSION CATHETER
K921247 · KRA
Target Therapeutics
Cardiovascular · 470d
Cleared Jun 29, 1993
NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY DEVICE
K921908 · FMF
Novo Nordisk Pharmaceuticals, Inc.
General Hospital · 432d
Cleared Jun 29, 1993
ARTHROSCOPE & ACCESSORIES
K921985 · HRX
Optimed Technologies, Inc.
Orthopedic · 427d
Cleared Jun 29, 1993
SONOPULS 591
K922036 · IMG
Henley Intl.
Physical Medicine · 424d
Cleared Jun 29, 1993
OMRON TYMPANIC THERMOMETER MC-500
K922344 · FLL
Omron Healthcare, Inc.
General Hospital · 406d
Cleared Jun 29, 1993
STERILE DENTAL KITS
K923902 · EKJ
Professional Sterile Systems, Inc.
Dental · 329d
Cleared Jun 29, 1993
CRI CYNOSAR CATHETER
K924227 · DRA
Catheter Research C/O Burditt, Bowles...
Cardiovascular · 312d
Cleared Jun 29, 1993
CVIS INSIGHT IMAGING CATHETER
K924922 · DQO
Cardiovascular Imaging Systems, Inc.
Radiology · 330d
Cleared Jun 29, 1993
HANDY VIBRO BELT
K925036 · ISA
Cosmesearch, Inc.
Physical Medicine · 267d
Cleared Jun 29, 1993
INFRARED LAMP
K925054 · ILY
Lumiscope Co., Inc.
Physical Medicine · 266d
Cleared Jun 29, 1993
OTI ORTHOPEDIC WIRE SYSTEM
K925447 · JDQ
Osteo Technology, Inc.
Orthopedic · 244d
Cleared Jun 29, 1993
BALT GUIDING CATHETER
K925632 · DQO
Target Therapeutics
Cardiovascular · 232d
Cleared Jun 29, 1993
MATRIX ELECDT & VACUPULLS
K930264 · LIH
Matrix Electromedical, Inc.
Neurology · 161d
Cleared Jun 29, 1993
DIRECT BILIRUBIN
K930679 · CIG
Horizon Diagnostics, Inc.
Chemistry · 140d
Cleared Jun 29, 1993
KODAK EKTASCAN IMAGELINK SYSTEM (KEIS)
K931551 · LMD
Eastman Kodak Company
Radiology · 92d
Cleared Jun 29, 1993
THE HILL ADJUSTABLE HA90
K931832 · INQ
Hill Laboratories Co.
Physical Medicine · 81d
Cleared Jun 29, 1993
QUICKVUE ONE-STEP HCG COMBO
K932042 · JHI
Quidel Corp.
Chemistry · 63d