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
84457–84480 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 1999
QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM
K992849 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 30d
Cleared Sep 23, 1999
ROTORBLADE SUTURE ANCHOR
K992938 · MAI
Li Medical Technologies, Inc.
Orthopedic · 23d
Cleared Sep 22, 1999
ORAL SLEEP DISORDER AID
K991209 · LRK
Perl-Rad Sleep Disorder Lab
Dental · 166d
Cleared Sep 22, 1999
BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT
K991398 · GXP
Stryker Leibinger
General & Plastic Surgery · 153d
Cleared Sep 22, 1999
NIC TONE ACRYLIC RESINS
K991577 · EBI
Manufacturera Dental Continental
Dental · 139d
Cleared Sep 22, 1999
BIOPRO RIMMED ACETABULAR COMPOMENT
K992144 · LZO
Biologically Oriented Prostheses
Orthopedic · 90d
Cleared Sep 22, 1999
CERANA
K992161 · EIH
Nordiska Dental AB
Dental · 89d
Cleared Sep 22, 1999
SAMSUNG RAYPAX DISPLAY WORKSTATION
K992306 · LLZ
Samsung Sds Co., Ltd.
Radiology · 75d
Cleared Sep 22, 1999
PYLON INTRAMEDULLAARY NAIL SYSTEM
K992350 · HSB
Alphatec Mfg., Inc.
Orthopedic · 70d
Cleared Sep 22, 1999
HEALTH-PLUS, SANITEX, RELIANCE POWER-FREE LATEX EXAMINATION GLOVE WITH...
K992364 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 69d
Cleared Sep 22, 1999
AURORA HL
K992374 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 69d
Cleared Sep 22, 1999
AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)
K992405 · GAW
Axya Medical, Inc.
General & Plastic Surgery · 64d
Cleared Sep 22, 1999
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
K992518 · EBC
Dentsply Intl.
Dental · 56d
Cleared Sep 22, 1999
HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400
K992609 · EBI
Kay See Dental Mfg. Co.
Dental · 49d
Cleared Sep 22, 1999
MITEK ROTATOR CUFF QUICKANCHOR PLUS
K992611 · HWC
Mitek Products
Orthopedic · 49d
Cleared Sep 22, 1999
SINFONY
K992645 · EBF
Espe Dental AG
Dental · 47d
Cleared Sep 22, 1999
CERADIUM NON-PRECIOUS CERAMIC ALLOY
K992705 · EJH
Matech, Inc.
Dental · 42d
Cleared Sep 22, 1999
CONVERTORS SURGICAL GOWNS
K992951 · FYA
Allegiance Healthcare Corp.
General Hospital · 21d
Cleared Sep 22, 1999
GE DIASONICS GATEWAY AND GATEWAY FX
K993069 · IYO
General Electric Co.
Radiology · 9d
Cleared Sep 21, 1999
MINI-LOGGER SERIES 2000
K991045 · GWK
Mini-Mitter Co., Inc.
Neurology · 176d
Cleared Sep 21, 1999
QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024
K991062 · LSR
Immunetics, Inc.
Microbiology · 174d
Cleared Sep 21, 1999
QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024
K991063 · LSR
Immunetics, Inc.
Microbiology · 174d
Cleared Sep 21, 1999
RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS
K991319 · IYE
Orfit Industries
Radiology · 155d
Cleared Sep 21, 1999
RADIONICS MICROELECTRODE KIT
K991399 · GXI
Radionics, Inc.
Neurology · 152d