FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
95521–95544 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 1997
VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE
K964138 · KPQ
Varian Medical Systems, Inc.
Radiology · 87d
Cleared Jan 10, 1997
WRITESTAR, AND VIEWSTAR
K964274 · LMB
Comview Corp.
Radiology · 77d
Cleared Jan 10, 1997
PHILIPS TOMOSCAN AV EXPANDER UPGRADE
K964318 · JAK
Philips Medical Systems North...
Radiology · 73d
Cleared Jan 10, 1997
MULTITAK SS SUTURE SYSTEM
K964324 · MBI
Bonutti Research
Orthopedic · 72d
Cleared Jan 10, 1997
PORTAREM-3000, PFS-6000
K964340 · EWO
Starkey Laboratories, Inc.
Ear, Nose, Throat · 71d
Cleared Jan 10, 1997
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K964370 · LNH
GE Medical Systems
Radiology · 70d
Cleared Jan 10, 1997
SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT
K964450 · HET
Pilling Weck Group
Obstetrics & Gynecology · 65d
Cleared Jan 10, 1997
GIANNI VERSACE SUNGLASSES, VERSUS SUNGLASSES, DIABLO SUNGLASSES
K964505 · HQY
I C Optics, Ltd.
Ophthalmic · 63d
Cleared Jan 10, 1997
PROFILE MAMMOGRAPHY SYSTEM (M-PRO)
K964576 · IZH
Bennett X-Ray Corp.
Radiology · 57d
Cleared Jan 10, 1997
CAP-AID (IMPROVED)
K964580 · FHA
Nebel, Inc.
Gastroenterology & Urology · 56d
Cleared Jan 10, 1997
GAMMA-GLUTAMYL TRANSPEPTIDASE
K964916 · JQB
Derma Media Lab., Inc.
Chemistry · 32d
Cleared Jan 10, 1997
ANSPACH MICROMAX SYSTEM
K965080 · ERL
The Anspach Effort, Inc.
Ear, Nose, Throat · 22d
Cleared Jan 09, 1997
PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)
K954331 · FPB
Pall Biomedical Products Co.
General Hospital · 482d
Cleared Jan 09, 1997
NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
K955393 · HIF
Surgical Innovations Plc
Obstetrics & Gynecology · 412d
Cleared Jan 09, 1997
AUTOLINK BODY PLETHYSMOGRAPH
K960121 · BZC
P.K. Morgan , Ltd.
Anesthesiology · 364d
Cleared Jan 09, 1997
LIGHTSTIC MODEL 360
K962965 · GEX
Rare Earth Medical, Inc.
General & Plastic Surgery · 163d
Cleared Jan 09, 1997
AMOILS EPITHELIAL SCRUBBER
K962989 · HOG
S. Percy Amoils
Ophthalmic · 161d
Cleared Jan 09, 1997
VOLLMAN PRONE POSITIONER
K963091 · IPT
Hill-Rom, Inc.
Physical Medicine · 154d
Cleared Jan 09, 1997
HERITAGE HIP SYSTEM
K963109 · JDI
Zimmer, Inc.
Orthopedic · 150d
Cleared Jan 09, 1997
MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL...
K963357 · MNH
Synthes (Usa)
Orthopedic · 136d
Cleared Jan 09, 1997
TENET RADIOLUCENT HAND TABLE
K963506 · FQO
Tenet Medical Engineering
General & Plastic Surgery · 128d
Cleared Jan 09, 1997
AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE
K964133 · KLE
American Dental Products, Inc.
Dental · 86d
Cleared Jan 09, 1997
MINI-SYMM BIPOLAR COAGULATOR
K964143 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 84d
Cleared Jan 09, 1997
SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL...
K964179 · EBF
S.S. White Mfg., Ltd.
Dental · 83d