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
101017–101040 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1995
SUNGLASSES & SPORT SUNGLASSES
K952963 · HQY
Wenzhou Winsor Optical International...
Ophthalmic · 78d
Cleared Sep 12, 1995
MEROCEL VAGINAL PACK
K953072 · EFQ
Merocel Corp.
General & Plastic Surgery · 74d
Cleared Sep 12, 1995
EVOLUTION MICROCATHETER
K953114 · DQO
Boston Scientific Corp
Cardiovascular · 71d
Cleared Sep 12, 1995
ARTICULATING RETRACTOR TISSUE RETRACTORS
K953348 · GCJ
Gm Engineering, Inc.
General & Plastic Surgery · 57d
Cleared Sep 12, 1995
ACCESS POINT
K953376 · GCJ
Access Surgical Intl., Inc.
General & Plastic Surgery · 56d
Cleared Sep 12, 1995
ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN
K953528 · LEH
Roche Diagnostic Systems, Inc.
Toxicology · 47d
Cleared Sep 12, 1995
RX12 LINEAR FULL SHELL AND IN THE CANAL
K953728 · ESD
Midwest City Hearing Aid Center
Ear, Nose, Throat · 33d
Cleared Sep 12, 1995
K AMP FULL SHELL AND IN THE EAR
K953729 · ESD
Midwest City Hearing Aid Center
Ear, Nose, Throat · 33d
Cleared Sep 12, 1995
NIL
K953782 · HQY
Dehang Industries, Ltd.
Ophthalmic · 29d
Cleared Sep 12, 1995
SOLARIX FV
K953832 · KPR
GE Medical Systems
Radiology · 27d
Cleared Sep 12, 1995
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K953918 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 25d
Cleared Sep 12, 1995
REVERT SUNGLASSES & POLAR SUNGLASSES
K953920 · HQY
Bella Occhiali, Inc.
Ophthalmic · 22d
Cleared Sep 12, 1995
SUNGLASSES
K953947 · HQY
Wenzhou Yian Optical International,...
Ophthalmic · 27d
Cleared Sep 12, 1995
HEARING AID (ALL-IN-THE-EAR)
K953960 · ESD
Audina Hearing Instrument
Ear, Nose, Throat · 21d
Cleared Sep 12, 1995
SUNGLASSES
K953989 · HQY
Morris & Sons Co.
Ophthalmic · 42d
Cleared Sep 12, 1995
TYMPASNOSTOMY TUBE
K953993 · ETD
Hampton Precision Products, Inc.
Ear, Nose, Throat · 19d
Cleared Sep 12, 1995
YEOU NAN SUNGLASSES FRAME MFG, CO., LTD.
K954075 · HQY
Yo Nan Sunglasses Co., Ltd.
Ophthalmic · 13d
Cleared Sep 12, 1995
GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE
K954155 · FCG
Promex, Inc.
Gastroenterology & Urology · 7d
Cleared Sep 11, 1995
DEUCE
K943244 · IQA
Apt Technology, Inc.
Physical Medicine · 432d
Cleared Sep 11, 1995
THE TULIP MONO-POLAR CAUTERY SPATULA
K952973 · GEI
The Tulip Mfg. Co.
General & Plastic Surgery · 76d
Cleared Sep 11, 1995
PTT 6200 ELEVATION THERAPY TABLE
K953622 · INQ
U.S. Table, Inc.
Physical Medicine · 39d
Cleared Sep 11, 1995
FASCIA CLOSURE DEVICE
K954011 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 17d
Cleared Sep 08, 1995
INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS
K924387 · FGE
Instent, Inc.
Gastroenterology & Urology · 1103d
Cleared Sep 08, 1995
ZETAPLUS (PUTTY)
K935890 · ELW
Zhermack Dental Production
Dental · 696d