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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
146041–146064 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 1985
DUODERM HYDROACTIVE DRESSING W/BORDER STERILE
K853844 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 60d
Cleared Nov 15, 1985
G-T 1000
K854020 · FTC
G-T Products
General & Plastic Surgery · 46d
Cleared Nov 15, 1985
JOHNS-ALLGOOD IRRIVAC DRIVE-IRRIGATOR/ASPIRATOR-
K854072
Dexide, Inc.
General & Plastic Surgery · 42d
Cleared Nov 15, 1985
ELLIPTI-PUNCH
K854159 · FZI
Alcon Laboratories
General & Plastic Surgery · 35d
Cleared Nov 15, 1985
GOODLEY POLYAXIAL CERVICAL TRACTION UNIT
K854248
E-Z-Em, Inc.
Orthopedic · 25d
Cleared Nov 15, 1985
TENSION-ISOMETER
K854254 · LXI
Medmetric Corp.
Orthopedic · 24d
Cleared Nov 15, 1985
SONGER TITANIUM SPINE-L-ROD
K854313 · KWP
Ortho-Engineering Products Co.
Orthopedic · 18d
Cleared Nov 15, 1985
CUI CHIN SIZER
K854339
Cox-Uphuff Intl.
General & Plastic Surgery · 18d
Cleared Nov 15, 1985
TECHNICARE 720 HPS CT SCANNER
K854340 · JAK
Technicare Corp.
Radiology · 18d
Cleared Nov 14, 1985
EBM-500
K840574 · DXN
Bosch Hearing Instruments, Inc.
Cardiovascular · 645d
Cleared Nov 14, 1985
LOGOS8821 1-CHANNEL DIRECT-WRITING ELECTROCARDIOGR
K851662 · DPS
Logos Medical Co., Ltd.
Cardiovascular · 205d
Cleared Nov 14, 1985
DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA
K852284 · LLZ
Digirad Corp.
Radiology · 169d
Cleared Nov 14, 1985
UNISTIM UNT-1
K852326 · GZB
Neuromed, Inc.
Neurology · 168d
Cleared Nov 14, 1985
GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY
K852460 · HGX
Healthteam
Obstetrics & Gynecology · 157d
Cleared Nov 14, 1985
CILAS MODEL YM101
K852761 · LLO
Inframed, Inc.
Anesthesiology · 139d
Cleared Nov 14, 1985
CR5 CARDIAC MONITOR
K852887 · DRT
Cardiac Recorders, Ltd.
Cardiovascular · 128d
Cleared Nov 14, 1985
MVP - 6000
K852909 · BZC
Waters Instruments, Inc.
Anesthesiology · 128d
Cleared Nov 14, 1985
PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM
K852968 · DSI
Personal Computers For Medicine, Inc.
Cardiovascular · 122d
Cleared Nov 14, 1985
CMV TEST
K853137 · GQI
Gull Laboratories, Inc.
Microbiology · 111d
Cleared Nov 14, 1985
DIGITAL SPHYGMOMANOMETER MODEL 7620
K853158 · DXN
Takeda Medical, Inc.
Cardiovascular · 107d
Cleared Nov 14, 1985
FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR
K853352 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 94d
Cleared Nov 14, 1985
SHILEY 3L CARDIOTOMY RESERVOIR
K853503 · DTP
Shiley, Inc.
Cardiovascular · 85d
Cleared Nov 14, 1985
SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM
K853516 · DTR
3M Health Care, Sarns
Cardiovascular · 84d
Cleared Nov 14, 1985
PRESSURE SENSING SYRINGE 65000
K853586 · DTL
Dlp, Inc.
Cardiovascular · 80d