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
85129–85152 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1999
ANSELL CONDOMS
K984392 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 225d
Cleared Jul 21, 1999
MEDRAD VISTRON CT INJECTOR SYSTEM
K991557 · DXT
Medrad, Inc.
Cardiovascular · 78d
Cleared Jul 21, 1999
EMS SWISS ORTHOCLAST
K991588 · HSZ
(Ems Sa) Electro Medical Systems
Orthopedic · 75d
Cleared Jul 21, 1999
PRO-GLASS
K991844 · EIH
Cad Cam Ventures
Dental · 54d
Cleared Jul 21, 1999
SCIMED ANGIOGRAPHIC CATHETERS
K992142 · DQO
Scimed
Cardiovascular · 27d
Cleared Jul 21, 1999
FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800
K992328 · DXN
Meditec Co., Ltd.
Cardiovascular · 9d
Cleared Jul 20, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM
K984180 · LFX
Zeus Scientific, Inc.
Microbiology · 239d
Cleared Jul 20, 1999
SYNOCTA PROSTHETICS
K990342 · DZE
Straumann USA
Dental · 166d
Cleared Jul 20, 1999
CHROMOPHARE D 530 LDR SURGICAL LIGHT
K990656 · FSY
Berchtold Holding GmbH
General & Plastic Surgery · 141d
Cleared Jul 20, 1999
OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM
K990712 · MJT
Howmedica Osteonics Corp.
Orthopedic · 138d
Cleared Jul 20, 1999
ENDOSCOPIC CAMERA
K991416 · GCJ
Genzyme Surgical Product (Genzyme...
General & Plastic Surgery · 88d
Cleared Jul 20, 1999
DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50
K991464 · GEX
Fisma, Inc.
General & Plastic Surgery · 84d
Cleared Jul 20, 1999
AWARE PAD
K991469 · IYO
Aac Consulting Group, Inc.
Radiology · 83d
Cleared Jul 20, 1999
DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF
K991525 · DXQ
Deroyal Industries, Inc.
Cardiovascular · 78d
Cleared Jul 20, 1999
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
K991608 · KMF
Dermaphylyx, Inc.
General & Plastic Surgery · 71d
Cleared Jul 20, 1999
DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING
K991609 · KMF
Dermaphylyx, Inc.
General & Plastic Surgery · 71d
Cleared Jul 20, 1999
ELEKTA STEREOTACTIC GUIDE
K991636 · HAW
Elekta Instrument AB
Neurology · 69d
Cleared Jul 20, 1999
SYNTHES CRANIAL FLAP TWIST CLAMP
K991860 · GXN
Synthes (Usa)
Neurology · 49d
Cleared Jul 20, 1999
Q-LITE 75 LIGHT CURE UNIT
K991865 · EBZ
Rolence Enterprise Co. , Ltd.
Dental · 49d
Cleared Jul 20, 1999
CICACARE MANAGEMENT FOR SCARS
K991957 · MDA
Smith & Nephew, Inc.
General & Plastic Surgery · 40d
Cleared Jul 20, 1999
SYNTHES CRANIAL FLAP TUBE CLAMP
K992000 · GXN
Synthes (Usa)
Neurology · 35d
Cleared Jul 19, 1999
SUMMER'S EVE LUBRICATING JELLY
K990597 · HIS
C.B. Fleet Co., Inc.
Obstetrics & Gynecology · 145d
Cleared Jul 19, 1999
MICROTOOLS
K991104 · MQH
Conception Technology, Inc.
Obstetrics & Gynecology · 109d
Cleared Jul 19, 1999
FERTILIZATION MEDIA-HTF
K991173 · MQL
Intl., Inc.
Obstetrics & Gynecology · 103d