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
107497–107520 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 1994
VISITEC PRECISE-POINT
K942234 · GAP
Visitec Co.
General & Plastic Surgery · 64d
Cleared Jul 12, 1994
PAUL SMITH SPECTACLES LTD. BY OLIVER PEOPLES, INC.
K942348 · HQZ
Oliver Peoples, Inc.
Ophthalmic · 56d
Cleared Jul 12, 1994
FRAME, SPECTACLE
K942463 · HQZ
Erica Optical Co.
Ophthalmic · 49d
Cleared Jul 12, 1994
SUNGLASSES TOKYO BAY
K942500 · HQY
Tokyo Bay, Inc.
Ophthalmic · 49d
Cleared Jul 12, 1994
NON-PRESCRIPTION SUNGLASSES
K942588 · HQY
Pro Axess
Ophthalmic · 41d
Cleared Jul 12, 1994
WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE
K942630 · KNW
Mill-Rose Laboratory
Gastroenterology & Urology · 39d
Cleared Jul 12, 1994
SCHOOL MASCOT EYEWEAR
K942652 · HQY
School Mascot Eyewear, Inc.
Ophthalmic · 39d
Cleared Jul 11, 1994
CARDIAC CATHETERIZATION TRAY
K931560 · DQO
Clinipad Corp.
Cardiovascular · 468d
Cleared Jul 11, 1994
AS/3 TM NETWORK
K933284 · CCK
Datex Division Instrumentarium Corp.
Anesthesiology · 370d
Cleared Jul 11, 1994
BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)
K934051 · GZJ
Skylark Device Co., Ltd.
Neurology · 326d
Cleared Jul 11, 1994
DISPOSABLE STETHOSCOPE HEAD COVER
K935146 · BZS
Modern Medical Devices, Inc.
Anesthesiology · 256d
Cleared Jul 11, 1994
E-Z DERM BIOSYNTHETIC WOUND DRESSING
K935189 · KGN
Brennen Medical, Inc.
General & Plastic Surgery · 258d
Cleared Jul 11, 1994
NEUROLOGICAL LEAD ACCESSORIES
K936099 · GZB
Medtronic Vascular
Neurology · 201d
Cleared Jul 11, 1994
M-K HYDROGEL DRESSING
K940409 · MGQ
Mason-Keller Corp.
General & Plastic Surgery · 165d
Cleared Jul 11, 1994
PROCATH PACING THRESHOLD CABLE
K941058 · DSA
Professional Catheter Corp.
Cardiovascular · 125d
Cleared Jul 11, 1994
AESCULAP NEUROENDOSCOPE
K941239 · GWG
Aesculap, Inc.
Neurology · 118d
Cleared Jul 11, 1994
MPM HYDROGEL
K942798 · MGQ
Mpm Medical., Inc.
General & Plastic Surgery · 26d
Cleared Jul 11, 1994
HYDROSKIN WOUND DRESSING
K942815 · KMF
Hymedix Intl., Inc.
General & Plastic Surgery · 26d
Cleared Jul 08, 1994
LOW PROFILE PASSPORT PUSH & PULL KITS & PEG TUBE
K920579 · KNT
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 879d
Cleared Jul 08, 1994
SARGON CYLINDRO-BLADE IMPLANT
K930071 · DZE
Sargon Ent., Inc.
Dental · 548d
Cleared Jul 08, 1994
SURGICAL DRAPE AND GOWN TRAY
K931456 · FYA
Custom Medical Products, Ltd.
General Hospital · 472d
Cleared Jul 08, 1994
COHERENT VERSAPULSE 2.1U /1.06U COMPACT SURGICAL LASER, MODELS A & B
K933318 · GEX
Lumenis, Inc.
General & Plastic Surgery · 354d
Cleared Jul 08, 1994
DISPOSABLE TAB ELECTRODE
K933803 · GXY
Cadwell Laboratories, Inc.
Neurology · 338d
Cleared Jul 08, 1994
CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION
K933906 · FBN
Fujinon, Inc.
Gastroenterology & Urology · 331d