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
108745–108768 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 1994
INTER TIP T
K934844 · HMX
Microsurgical Technology, Inc.
Ophthalmic · 193d
Cleared Apr 19, 1994
R & D BATTERIES, INC. PART NUMBER 5113
K935244 · ILQ
R & D Batteries, Inc.
Physical Medicine · 169d
Cleared Apr 19, 1994
R & D BATTERIES, INC. PART NUMBER 5447
K935467 · BXB
R & D Batteries, Inc.
Physical Medicine · 169d
Cleared Apr 19, 1994
KING'S SUNGLASS CORP.
K935943 · HQY
King'S Sunglass Corp.
Ophthalmic · 127d
Cleared Apr 19, 1994
ROTA DATAMATE I
K935945 · HMF
Rota Systems,Inc.
Ophthalmic · 127d
Cleared Apr 19, 1994
ROTA SYSTEM 5000
K935952 · HMF
Rota Systems Medfurniture, Inc.
Ophthalmic · 127d
Cleared Apr 19, 1994
MIS ELECTROSURGICAL ELECTRODES
K940192 · GEI
National Wire & Stamping, Inc.
General & Plastic Surgery · 96d
Cleared Apr 19, 1994
NEW EYES EYEGLASS FRAME
K940250 · HQY
Sunrise International Business
Ophthalmic · 88d
Cleared Apr 19, 1994
COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEM
K940484 · IZI
Siemens Medical Solutions USA, Inc.
Radiology · 76d
Cleared Apr 19, 1994
PROPHY PASTE
K940496 · EJR
Challenge Products, Inc.
Dental · 76d
Cleared Apr 19, 1994
DOUBLE TRACH SEIVEL CONNECTOR
K940544 · BZA
Fvtnks
Anesthesiology · 71d
Cleared Apr 19, 1994
SCIMED 8 FRENCH TRIGUIDE GUIDING CATHETER
K940603 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 69d
Cleared Apr 19, 1994
SYSTEM 22 ADULT MASK
K940887 · BYG
Medic-Aid , Ltd.
Anesthesiology · 53d
Cleared Apr 19, 1994
SYSTEM 22 PAEDIATRIC MASK
K940888 · BYG
Medic-Aid , Ltd.
Anesthesiology · 53d
Cleared Apr 19, 1994
AESCULAP ENDOSCOPIC INSTRUMENTS
K940936 · GEI
Aesculap, Inc.
General & Plastic Surgery · 50d
Cleared Apr 19, 1994
CONMED T.D.S. ELECTROSURGICAL GROUND PAD
K941160 · GEI
Conmedcorp
General & Plastic Surgery · 39d
Cleared Apr 19, 1994
PLATEX TAMPONS MODEL NUMBER 07094
K941196 · HIL
Playtex Family Products, Inc.
Obstetrics & Gynecology · 36d
Cleared Apr 19, 1994
SONGER CABLE SYSTEM
K941213 · JDQ
Pioneer Surgical Technology
Orthopedic · 41d
Cleared Apr 19, 1994
INNERSENSE DISPOSABLE MICROTRANSDUCER
K941283 · DXO
Becton Dickinson Vascular Access, Inc.
Cardiovascular · 33d
Cleared Apr 19, 1994
TRAKEEZ
K941384 · CBH
Ergomed, Inc.
Anesthesiology · 28d
Cleared Apr 19, 1994
TISSUE ISOLATION AND RETRIEVAL BAG
K941500 · GCJ
Advanced Surgical, Inc.
General & Plastic Surgery · 21d
Cleared Apr 19, 1994
BARRIERBAC AND BARRIERBAC S
K941536 · CAH
Mallinckrodt Medical
General Hospital · 20d
Cleared Apr 19, 1994
BIOPSY NEEDLE AND HOUSING
K941549 · KNW
Biopsys Medical, Inc.
Gastroenterology & Urology · 20d
Cleared Apr 19, 1994
HYGROSTER
K941585 · BYD
Mallinckrodt Medical
Anesthesiology · 19d