FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
84961–84984 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 1999
MOSS MIAMI 6.35MM POLYAXIAL SCREW
K992168 · KWQ
Depuyacromed
Orthopedic · 87d
Cleared Sep 23, 1999
MIRACLEBREATH TONGUE CLEANER
K992270 · LCN
Stellar Labs, Inc.
Dental · 79d
Cleared Sep 23, 1999
MICRO-FRANCE LIPOSUCTION CANNULAS
K992282 · QPB
Xomed, Inc.
General & Plastic Surgery · 78d
Cleared Sep 23, 1999
SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)
K992348 · JDS
Synthes (Usa)
Orthopedic · 71d
Cleared Sep 23, 1999
EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS
K992367 · HWC
Electro-Biology, Inc.
Orthopedic · 70d
Cleared Sep 23, 1999
ARTHROSCOPE / MEDIFIX INC.
K992474 · HRX
Medifix, Inc.
Orthopedic · 59d
Cleared Sep 23, 1999
MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES
K992480 · HET
Medifix, Inc.
Obstetrics & Gynecology · 59d
Cleared Sep 23, 1999
A-18 HEMODIALYZER
K992565 · FJI
Althin Medical AB
Gastroenterology & Urology · 52d
Cleared Sep 23, 1999
PHOTON RADIOSURGERY SYSTEM (PRS)
K992577 · JAD
Photoelectron Corporation
Radiology · 52d
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