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
116401–116424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 1992
INTER-HA HIP PROSTHESIS
K921672 · MEH
Kirschner Medical Corp.
Orthopedic · 121d
Cleared Aug 07, 1992
ACS ANGIOTRAK(TM) SYSTEM
K921719 · MAV
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 120d
Cleared Aug 07, 1992
VAS DILATOR
K922192 · KOA
Cook Urological, Inc.
Gastroenterology & Urology · 88d
Cleared Aug 07, 1992
ELECTRONIC PHOTOSPOT 20
K922240 · JAA
Toshiba America Medical Systems, In.C
Radiology · 86d
Cleared Aug 07, 1992
MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE
K922544 · FST
Kirschner Medical Corp.
General & Plastic Surgery · 70d
Cleared Aug 07, 1992
WILLIAMS ADVANTAGE ELEVATION TABLE
K922719 · INQ
Williams Manufacturing Co.
Physical Medicine · 63d
Cleared Aug 06, 1992
LAP SPONGES, MODIFIED
K913303 · GDY
Carwild Corp.
General & Plastic Surgery · 378d
Cleared Aug 06, 1992
SCALAMOBIL
K920105 · ING
Alber Technologies, Inc.
Physical Medicine · 210d
Cleared Aug 06, 1992
SPECIALTY SPONGES
K920355 · GDY
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 192d
Cleared Aug 06, 1992
SURGICAL SPONGES
K920356 · GDY
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 192d
Cleared Aug 06, 1992
ENDOPATH ILS ENDOSCOPIC CIRCULAR STAPLER
K920752 · GDW
Ethicon, Inc.
General & Plastic Surgery · 169d
Cleared Aug 06, 1992
LAPAROMED LIGATING LOOP
K921053 · KCJ
Laparomed Corp.
Ear, Nose, Throat · 154d
Cleared Aug 06, 1992
BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540
K921165 · DWJ
Augustine Medical, Inc.
Cardiovascular · 148d
Cleared Aug 06, 1992
INSTRUMENT IRRIGATION PUMP
K921253 · KOD
Psi Medical Products, Inc.
Gastroenterology & Urology · 143d
Cleared Aug 06, 1992
ALPHATEC SMALL FRAGMENT SET
K922166 · HWC
Alphatec Mfg., Inc.
Orthopedic · 90d
Cleared Aug 06, 1992
ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES
K922167 · HRS
Alphatec Mfg., Inc.
Orthopedic · 90d
Cleared Aug 06, 1992
HEALTHPAK CHAIR SOX BARRIERS
K922175 · KLC
Healthpak, Inc.
Dental · 90d
Cleared Aug 06, 1992
HEM-O-LOK -- MODIFICATION
K922186 · GDW
Linvatec Corp.
General & Plastic Surgery · 161d
Cleared Aug 06, 1992
RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1
K922570 · EPF
Resound Corp.
Ear, Nose, Throat · 66d
Cleared Aug 06, 1992
CAVI-ZYME
K922633 · EJB
E&D Dental Products, Inc.
Dental · 78d
Cleared Aug 06, 1992
HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE
K922739 · GBX
Hollister, Inc.
General & Plastic Surgery · 59d
Cleared Aug 06, 1992
ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS
K923159 · ILJ
Arjo-Century, Inc.
Physical Medicine · 38d
Cleared Aug 06, 1992
NAICO WHEEL CHAIRS
K923291 · IOR
Naico Corp.
Physical Medicine · 31d
Cleared Aug 06, 1992
BTE HEARING AID OTICON MODEL: MULTIFOCUS POWER
K923388 · ESD
Oticon Corp.
Ear, Nose, Throat · 30d