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
114601–114624 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 1993
POWDER FREE EXAMINATION GLOVE
K915157 · LYY
American Pro Latex, Inc.
General Hospital · 446d
Cleared Feb 02, 1993
HEMO-CATH SILICONE ACCESS CATHETER
K915423 · LFJ
Medical Components, Inc.
Gastroenterology & Urology · 428d
Cleared Feb 02, 1993
PHOTOPHONE(R) MULTI VIEW(TM)
K922267 · LLZ
Image Data Corp.
Radiology · 264d
Cleared Feb 02, 1993
ALWAYS CONTOURS UNSCENTED MENSTRUAL PADS
K922575 · HHD
Procter & Gamble Co.
Obstetrics & Gynecology · 246d
Cleared Feb 02, 1993
IMMUCHEM LH-MW ELISA
K922944 · CEP
Icn Biomedicals, Inc.
Chemistry · 229d
Cleared Feb 02, 1993
ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION
K923077 · JAK
GE Medical Systems
Radiology · 222d
Cleared Feb 02, 1993
MEMORY WIRE
K923709 · EJF
Wire Products
Dental · 190d
Cleared Feb 02, 1993
MEDVISION(TM) IMAGING SOFTWARE
K924178 · LMD
Evergreen Technologies, Inc.
Radiology · 167d
Cleared Feb 02, 1993
EN TYPING CIE KIT FOR DIAGNOSTIC USE
K925118 · LLL
The Binding Site, Ltd.
Immunology · 162d
Cleared Feb 02, 1993
PSI 220 DUAL EMG
K925197 · HCC
Fasstech
Neurology · 110d
Cleared Feb 02, 1993
MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT
K925263 · BZA
Merit Medical Systems, Inc.
Anesthesiology · 106d
Cleared Feb 02, 1993
STOCKERT 1/4 BUBBLE SENSOR
K925541 · KRL
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 91d
Cleared Feb 02, 1993
GSI 38 AUTO TYMP
K925585 · ETY
Lucas Grason-Stadler, Inc.
Ear, Nose, Throat · 90d
Cleared Feb 02, 1993
OLYMP-X,X-RAY GENERATOR
K925684 · IZO
Afp Imaging Corp.
Radiology · 82d
Cleared Feb 02, 1993
VISTA HP/HPQ SYSTEM
K925845 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 76d
Cleared Feb 02, 1993
WIDEX MODEL D16
K926085 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 62d
Cleared Feb 02, 1993
SAS ONE STEP PREGNANCY
K926204 · JHI
Sa Scientific, Inc.
Chemistry · 55d
Cleared Feb 02, 1993
SOUNDCHOICE WITH VARIABLE SLOPE
K926476 · ESD
Bausch & Lomb, Inc.
Ear, Nose, Throat · 35d
Cleared Feb 01, 1993
SECHRIST IV-100B SAVI SYSTEM
K920121 · CBK
Sechrist
Anesthesiology · 385d
Cleared Feb 01, 1993
ULTRACELL EAR WICK
K920357 · KCN
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 371d
Cleared Feb 01, 1993
AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH
K922123 · GCI
United States Surgical, A Division of...
General & Plastic Surgery · 271d
Cleared Feb 01, 1993
CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT
K923463 · LLH
Techlab, Inc.
Microbiology · 202d
Cleared Feb 01, 1993
5701, 5702, 5704, 5706 HYGROSCOPIC CONDENSER HUMID
K923865 · BYD
Vital Signs, Inc.
Anesthesiology · 182d
Cleared Feb 01, 1993
THE ENDO OPTIKS MICROPROBE
K924090 · HQB
Endo Optics, Inc.
Ophthalmic · 172d