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
110881–110904 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 1993
SCIMED(R) DISPATCH(TM) CORONARY INFUSION CATHETER
K932616 · KRA
Scimed Life Systems, Inc.
Cardiovascular · 197d
Cleared Dec 15, 1993
AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM
K933267 · LJM
Zeus Scientific, Inc.
Immunology · 162d
Cleared Dec 15, 1993
POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE)
K933664 · IZI
Siemens Gammasonics, Inc.
Radiology · 140d
Cleared Dec 15, 1993
PAL (PERSONAL AMPLIFIER FOR LISTENING)
K933963 · ESD
Hearing Care Products, Inc.
Ear, Nose, Throat · 121d
Cleared Dec 15, 1993
PANORAMIC X-RAY UNITS, MODIFICATION
K934063 · EHD
Planmeca Oy
Radiology · 106d
Cleared Dec 15, 1993
ACTION WIZARD PEDIATRIC MANUAL WHEELCHAIR
K934646 · IOR
Invacare Corp.
Physical Medicine · 85d
Cleared Dec 15, 1993
MPQ-42
K934944 · IZP
Elema-Schonander, Inc.
Radiology · 58d
Cleared Dec 15, 1993
8260 SERIES 3M PROGRAMMABLE HEARING INSTRUMENTS
K935095 · ESD
3M Company
Ear, Nose, Throat · 51d
Cleared Dec 15, 1993
MIRACLE EAR MODEL SHARP II CANAL
K935265 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 15, 1993
MIRACLE EAR MODEL SHARP II MICRO CANAL HEARING AID
K935266 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 15, 1993
NUCLEAR ASSOCIATES KNIGHT SR., KNIGHT JR. AND SESAM PORTABLE RADIOGRAPHY...
K935397 · IXA
Victoreen, Inc.
Radiology · 36d
Cleared Dec 15, 1993
SOUNDRIGHT, SHP
K935420 · ESD
Soundright Hearing Products
Ear, Nose, Throat · 36d
Cleared Dec 14, 1993
KAWASUMI LABORATORIES K-CUFF
K930012 · KZD
Kawasumi Laboratories Co., Ltd.
General Hospital · 344d
Cleared Dec 14, 1993
KONICA SRX-501A AUTOMATIC X-RAY FILM PROCESSOR
K931315 · IXW
Konica Medical Corp.
Radiology · 274d
Cleared Dec 14, 1993
KONICA DS-7 AUTOMATIC X-RAY FILM PROCESSOR
K931316 · IXW
Konica Medical Corp.
Radiology · 274d
Cleared Dec 14, 1993
KONICA SRX-301 AUTOMATIC X-RAY FILM PROCESSOR
K931317 · IXW
Konica Medical Corp.
Radiology · 274d
Cleared Dec 14, 1993
IMAGEACCESS SYSTEM
K931454 · LNH
Image Premastering Services, Inc.
Radiology · 266d
Cleared Dec 14, 1993
MERIT
K931656 · LNH
Picker International
Radiology · 253d
Cleared Dec 14, 1993
PHASED ARRAY/BILATERAL QUADRATURE CONTOUR COIL
K932091 · LNH
Magnetic Research, Inc.
Radiology · 228d
Cleared Dec 14, 1993
ZEISS OPMILAS 144 SURGICAL LASERS
K932376 · GEX
Carl Zeiss, Inc.
General & Plastic Surgery · 211d
Cleared Dec 14, 1993
HUBER NEEDLE INFUSION SET
K932638 · FPA
Douglas Medical Products Corp.
General Hospital · 195d
Cleared Dec 14, 1993
CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH
K933050 · FOZ
Critikon Company, LLC
General Hospital · 208d
Cleared Dec 14, 1993
BARE-FIBER ENDOILLUMINATOR
K933208 · HQE
Surgical Technologies, Inc.
Ophthalmic · 166d
Cleared Dec 14, 1993
MERIT
K933356 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 158d