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
148729–148752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 1985
FC-700 DEFIBRILLATOR
K850618 · LDD
Fukuda Denshi USA, Inc.
Cardiovascular · 63d
Cleared Apr 19, 1985
OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE
K850623 · DTB
Oscor Medical Corp.
Cardiovascular · 59d
Cleared Apr 19, 1985
INTERMEDICS BONE SCREW
K850770 · HWC
Intermedics Orthopedics
Orthopedic · 53d
Cleared Apr 19, 1985
COMPRESSION HIP SCREW SYSTEM
K850886 · KIT
Pfizer, Inc.
Pathology · 46d
Cleared Apr 19, 1985
HDC SILCATH SUBCLAVIAN CATHETER PERCUTANEOUS INSER
K851078 · DYB
Hdc Corp.
Cardiovascular · 32d
Cleared Apr 19, 1985
PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD
K851145 · DTD
Pacesetter Systems
Cardiovascular · 29d
Cleared Apr 19, 1985
NUMED BALLOON PACING CATHETER
K851246 · LDF
NuMED, Inc.
Cardiovascular · 25d
Cleared Apr 19, 1985
AMENDMENT LIFEPAK 200, NPN 046
K851247 · DRO
Physio-Control Corp.
Cardiovascular · 43d
Cleared Apr 19, 1985
AMENDMENT LIFEPAK 100, NPN 045
K851248 · DRO
Physio-Control Corp.
Cardiovascular · 43d
Cleared Apr 19, 1985
MICROSPIRO-SDS
K851277 · BZG
Medical Equipment Designs, Inc.
Anesthesiology · 18d
Cleared Apr 19, 1985
BROM CRESOL PURPLE STARCH
K851343 · JSH
Micro Media Laboratories
Microbiology · 15d
Cleared Apr 19, 1985
PURPLE BROTH
K851345 · JSH
Micro Media Laboratories
Microbiology · 15d
Cleared Apr 19, 1985
PHENYLALANINE AGAR
K851346 · JSH
Micro Media Laboratories
Microbiology · 15d
Cleared Apr 19, 1985
KANAMYCIN-VANCOMYCIN-LAKED BLOOD AGAR
K851347 · JSJ
Micro Media Laboratories
Microbiology · 15d
Cleared Apr 19, 1985
COBA AGAR
K851348 · JSJ
Micro Media Laboratories
Microbiology · 15d
Cleared Apr 18, 1985
AUSONICS 150
K843971 · IYO
Ausonics Pty , Ltd.
Radiology · 189d
Cleared Apr 18, 1985
AUSONICS 357
K843994 · IYO
Ausonics Pty , Ltd.
Radiology · 189d
Cleared Apr 18, 1985
COPAL DIGITAL SPHYGMOMAMOMETER UA-550
K844285 · DXN
Takeda Medical, Inc.
Cardiovascular · 164d
Cleared Apr 18, 1985
CORNEOMAP 4500
K844299 · IYO
Radionics Medical, Inc.
Radiology · 162d
Cleared Apr 18, 1985
BLOOD-PRESSURE ECG TRANSMITTER
K844310 · DXN
Instromedix, Inc.
Cardiovascular · 163d
Cleared Apr 18, 1985
POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000
K844396 · DSK
Associated Mills, Inc.
Cardiovascular · 156d
Cleared Apr 18, 1985
POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000
K844397 · DSK
Associated Mills, Inc.
Cardiovascular · 156d
Cleared Apr 18, 1985
LEPTOS PULSE GENERATOR
K844794 · DXY
Biotronik Sales, Inc.
Cardiovascular · 129d
Cleared Apr 18, 1985
NEOS-M PULSE GENERATOR
K844795 · DXY
Biotronik Sales, Inc.
Cardiovascular · 129d