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
108529–108552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 1994
CONQUEST GINGA-BLEND
K941375 · EBF
Jeneric/Pentron, Inc.
Dental · 41d
Cleared May 02, 1994
CONQUEST SENIOR
K941376 · EBF
Jeneric/Pentron, Inc.
Dental · 41d
Cleared May 02, 1994
PROCOM
K941378 · EBF
Jeneric/Pentron, Inc.
Dental · 41d
Cleared Apr 29, 1994
PHILIPS DCI-SX
K921219 · OWB
Philips Medical Systems, Inc.
Radiology · 777d
Cleared Apr 29, 1994
LUXATEMP AUTOMIX
K924830 · EBG
Dmg Chemisch Pharmazeutische Fabrik GmbH
Dental · 581d
Cleared Apr 29, 1994
SHARPS CONTAINMENT SYSTEM
K925816 · FMI
Post Medical, Inc.
General Hospital · 528d
Cleared Apr 29, 1994
SHAIDS PROTECTIVE GLASSES
K930347 · HOY
Depuy, Inc.
Ophthalmic · 459d
Cleared Apr 29, 1994
SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST
K930891 · KWP
Synthes (Usa)
Orthopedic · 431d
Cleared Apr 29, 1994
COOL CUT
K931429 · HWE
Mitab
Orthopedic · 403d
Cleared Apr 29, 1994
RMHS MONOLITHIC FEMORAL COMPONENT
K931642 · LPH
Smith & Nephew Richards, Inc.
Orthopedic · 392d
Cleared Apr 29, 1994
EYSOTEK
K932132 · FXX
Isotech Corp.
General Hospital · 361d
Cleared Apr 29, 1994
EYSOTEK
K932133 · FXX
Isotech Corp.
General Hospital · 361d
Cleared Apr 29, 1994
INMAN IRRIGATION TAPERED PROBE
K933171 · KYZ
Inman Medical Corp.
General Hospital · 304d
Cleared Apr 29, 1994
EXACTECH ALL POLY ACETABULAR CUP
K934253 · JDZ
Exactech, Inc.
Orthopedic · 241d
Cleared Apr 29, 1994
HOME AMB-ALERT
K934344 · KMI
Medway
General Hospital · 233d
Cleared Apr 29, 1994
CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR
K934706 · GEX
Candela Laser Corp.
General & Plastic Surgery · 211d
Cleared Apr 29, 1994
TRILOGY ACETABULAR SYSTEM
K934765 · LPH
Zimmer, Inc.
Orthopedic · 206d
Cleared Apr 29, 1994
NON-PRESCRIPTION SUNGLASSES
K935037 · HQY
Xiamen Chenyi Plastics Industrial Co....
Ophthalmic · 193d
Cleared Apr 29, 1994
CROWN SUNGLASSES
K936103 · HQY
Capo, Inc.
Ophthalmic · 128d
Cleared Apr 29, 1994
KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS
K936116 · LMD
Eastman Kodak Company
Radiology · 127d
Cleared Apr 29, 1994
LEARN MODE WATERPROOF PENDANT PANIC BUTTON
K940223 · IQA
Interactive Technologies, Inc.
Physical Medicine · 101d
Cleared Apr 29, 1994
ACUSON PICTURE ARCHIVING & COMMUNICATION SYSTEM MODIFICATION
K940285 · IYN
Acuson Corp.
Radiology · 109d
Cleared Apr 29, 1994
TECNADYNE 20/20 FOG INHIBITOR KIT
K940431 · GCJ
Tecnadyne Scientific, Inc.
General & Plastic Surgery · 88d
Cleared Apr 29, 1994
MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF)
K940459 · EMA
Dentsply Intl.
Dental · 87d