FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
127081–127104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 1990
PROTEX LATEX EXAMINATION GLOVE
K900790 · LYY
Seyen Intl., Inc.
General Hospital · 44d
Cleared Apr 05, 1990
O.R. DATA MANAGER
K900937 · BSZ
Draeger Medical, Inc.
Anesthesiology · 36d
Cleared Apr 05, 1990
BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE
K901054 · LSR
Bion Ent., Ltd.
Microbiology · 30d
Cleared Apr 05, 1990
MODEL 8010
K901092 · LNH
Medical Advances, Inc.
Radiology · 29d
Cleared Apr 04, 1990
BONE PLATE
K893201 · HRS
Karlin Technology, Inc.
Orthopedic · 343d
Cleared Apr 04, 1990
BONE SCREW
K893203 · JDR
Karlin Technology, Inc.
Orthopedic · 343d
Cleared Apr 04, 1990
PROVIEW SELF-SEALING STERILIZATION POUCH
K893802 · KCT
Cottrell, Ltd.
General Hospital · 317d
Cleared Apr 04, 1990
SURGEON'S GLOVES
K894087 · KGO
Shangrila Latex Industries Pvt. , Ltd.
General Hospital · 300d
Cleared Apr 04, 1990
OSSEODENT DENTAL ATTACHMENTS
K895462 · DZE
Collagen Corp.
Dental · 210d
Cleared Apr 04, 1990
MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM
K895801 · DRT
Marquette Electronics, Inc.
Cardiovascular · 188d
Cleared Apr 04, 1990
ELATEC HOLTER ANALYZER
K895806 · DSI
Ela Medical, Inc.
Cardiovascular · 188d
Cleared Apr 04, 1990
RESUSO MASK
K895820 · BTM
Rml Ent., Inc.
Anesthesiology · 190d
Cleared Apr 04, 1990
SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN)
K895889 · EIH
Leach and Dillon Co., Inc.
Dental · 181d
Cleared Apr 04, 1990
VISITEC VITRECTOMY UNIT
K896622 · HKP
Visitec Co.
Ophthalmic · 134d
Cleared Apr 04, 1990
BOWEN ELECTRODE SKIN PREPATORY CLEANSER
K896898 · LKB
Bowen & Company, Inc.
General Hospital · 117d
Cleared Apr 04, 1990
INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA.
K897093 · HNF
Microline Pentax, Inc.
Ophthalmic · 105d
Cleared Apr 04, 1990
MITEK ANCHOR(TM)
K897155 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 99d
Cleared Apr 04, 1990
MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR
K900091 · HQG
Onufryk Low Vision Ent.
Ophthalmic · 89d
Cleared Apr 04, 1990
AUTO SUTURE SURGIPORT SPIRAL SLEEVE
K900123 · FBQ
United States Surgical, A Division of...
General & Plastic Surgery · 85d
Cleared Apr 04, 1990
SHARPLAN ND:YAG LASER LAPAROSCOPIC CHOLECYSTECTOMY
K900346 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 71d
Cleared Apr 04, 1990
SALIVA ABSORBER - DENTAL
K900631 · DYN
Kab Gloves Unltd.
Dental · 55d
Cleared Apr 04, 1990
HEARING AID (ALL-IN-THE-EAR)
K900789 · ESD
Solar Aid Corp.
Ear, Nose, Throat · 43d
Cleared Apr 04, 1990
CARDISUNY, 501BX
K900849 · LOS
Graham-Field, Inc.
Cardiovascular · 41d
Cleared Apr 04, 1990
DAHLBERG MODEL JH IN-THE-EAR HEARING INSTRUMENT
K900861 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 40d