FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
126121–126144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1990
INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE GUN
K896933 · KNW
The Witmoore Group, Inc.
Gastroenterology & Urology · 193d
Cleared Jun 22, 1990
MARTIN-HENSLEY SEGMENT LENS
K897021 · HPX
Bruce W. Martin O.D. and Edward Hensley
Ophthalmic · 185d
Cleared Jun 22, 1990
PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER
K900317 · KRB
Elecath
Cardiovascular · 150d
Cleared Jun 22, 1990
SHIELDED PIGGYBACK IV NEEDLE
K900353 · FPA
Pascall Saringia Medical Corp.
General Hospital · 148d
Cleared Jun 22, 1990
O-RING PROSTHETIC ATTACHMENT DEVICE
K900545 · DZE
Calcitek, Inc.
Dental · 137d
Cleared Jun 22, 1990
ACUDATA INDICATENS MODEL 5A
K900596 · GZJ
Acudata Software
Neurology · 134d
Cleared Jun 22, 1990
ACUDATA INDICATENS MODEL 5XS
K900668 · GZJ
Acudata Software
Neurology · 129d
Cleared Jun 22, 1990
MEDILASE SERIES 2100 ENDOSCOPE
K900894 · GCQ
Medical Laser, Inc.
Gastroenterology & Urology · 115d
Cleared Jun 22, 1990
NON-PRESCRIPTION SUNGLASSES
K900936 · HQY
Barkley House, Inc.
Ophthalmic · 114d
Cleared Jun 22, 1990
TRIA-SONIC ULTRA SOUND TRANSMISSION GEL
K901217 · JOT
H & P Industries, Inc.
General & Plastic Surgery · 101d
Cleared Jun 22, 1990
BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON
K901427 · FGE
Telemed Systems, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 22, 1990
ALBERT MORTON UROLOGICAL CATHETER
K901441 · GBM
Transinternational Marketing Group
Gastroenterology & Urology · 87d
Cleared Jun 22, 1990
NUTRICARE ENFUTEC 1000 ENTERAL FEEDING PUMP
K901458 · LZH
Clinical Systems, Inc.
General Hospital · 86d
Cleared Jun 22, 1990
OLYMPIC SMART SCALE PEDIATRICS MODEL 50
K901522 · FRW
Olympic Medical Corp.
General Hospital · 81d
Cleared Jun 22, 1990
DOBBHOFF BILIARY STENT SET
K901582 · FGE
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 79d
Cleared Jun 22, 1990
SHIN NIPPON AUTO REFRACTOMETER QR-007N
K901583 · HKO
Soderberg, Inc.
Ophthalmic · 79d
Cleared Jun 22, 1990
OHMEDA - OHIO(R) CARE PLUS INCUBATOR
K901585 · FMZ
Ohmeda Medical
General Hospital · 79d
Cleared Jun 22, 1990
DIAMOND ND:YAG OPHTHALMIC LASER
K901636 · GEX
Biovision, Inc.
General & Plastic Surgery · 74d
Cleared Jun 22, 1990
CAREFREE(TM) FESTIVA PANTYSHIELDS
K901664 · HHD
Personal Products Co.
Obstetrics & Gynecology · 73d
Cleared Jun 22, 1990
PALADON(R) 65
K901789 · EBI
Kulzer, Inc.
Dental · 64d
Cleared Jun 22, 1990
ALLEVYN DRESSING (LABELING REVISED)
K901877 · KMF
Smith & Nephew United, Inc.
General & Plastic Surgery · 57d
Cleared Jun 22, 1990
INTRASITE GEL (LABELING REVISION)
K901878 · KMF
Smith & Nephew United, Inc.
General & Plastic Surgery · 57d
Cleared Jun 22, 1990
INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING)
K901879 · KGX
Smith & Nephew United, Inc.
General & Plastic Surgery · 57d
Cleared Jun 22, 1990
SILAMAT (AMALGAMATOR)
K901909 · EFD
Ivoclar North America, Inc.
Dental · 56d