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
102721–102744 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 1995
PRECISION BIPOLAR COAGULATOR
K951985 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 26d
Cleared May 22, 1995
FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND
K931265 · JWI
Ferguson Medical
Orthopedic · 805d
Cleared May 22, 1995
INSALL-BURSTEIN II
K935080 · JWH
Hospital For Special Surgery
Orthopedic · 574d
Cleared May 22, 1995
SELECT(R) SHOULDER ALL POLY GLENOID
K935802 · KWS
Intermedics Orthopedics
Orthopedic · 536d
Cleared May 22, 1995
NATURAL-KNEE II SYSTEM
K936159 · JWH
Intermedics Orthopedics
Orthopedic · 515d
Cleared May 22, 1995
NOBLES-LAI VIDEO IMAGING SYSTEM
K940273 · GWG
Visioneering, Inc.
Neurology · 486d
Cleared May 22, 1995
FNA BIOPSY NEEDLE
K941722 · FCG
Betta Medical, Inc.
Gastroenterology & Urology · 410d
Cleared May 22, 1995
NIHON KOHDEN ELECTROENCEPHALOGRAPH
K944678 · GWQ
Nihon Kohden America, Inc.
Neurology · 242d
Cleared May 22, 1995
MITEK TOGGLE ANCHOR(TM)
K950070 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 133d
Cleared May 22, 1995
SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR
K950384 · LXT
Synthes (Usa)
Orthopedic · 110d
Cleared May 22, 1995
HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR
K950483 · DRO
Hewlett-Packard Co.
Cardiovascular · 108d
Cleared May 22, 1995
HEMI-SHOULDER PROSTHESIS
K950594 · HSD
Encore Orthopedics, Inc.
Orthopedic · 102d
Cleared May 22, 1995
POSTERIOR CAPSULE SHIELD
K950798 · HQC
Oasis Medical, Inc.
Ophthalmic · 90d
Cleared May 22, 1995
PRO-PAK FOR OMS DIPLOMATE
K950800 · HQC
M. Imonti and Associates Inc.,
Ophthalmic · 90d
Cleared May 22, 1995
PROFORM CEMENTED FEMORAL COMPONENT
K951083 · JDG
Stelkast Company
Orthopedic · 74d
Cleared May 22, 1995
ENDOTRACHEAL TUBE
K951696 · BTR
Unomedical Sdn Bhd
Anesthesiology · 40d
Cleared May 22, 1995
PEDIATRIC ENDOTRACHEAL TUBE
K951697 · BTR
Unomedical Sdn Bhd
Anesthesiology · 40d
Cleared May 22, 1995
PRIMA VENTILATOR HOSES
K952010 · BZO
Prima, Inc.
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA BREATHING BAGS
K952011 · BZO
Prima, Inc.
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA CUSTOM ANESTESIA CIRCUIT
K952012 · BZO
Prima, Inc.
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA GUEDEL AIRWAYS
K952013 · BTR
Prima, Inc.
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
K952014 · CAI
Prima, Inc.
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA FILTER
K952015 · CAH
Prima, Inc.
General Hospital · 24d
Cleared May 22, 1995
PRIMA PEDIATRIC GAS SAMPLING CIRCUITS
K952016 · CAI
Prima, Inc.
Anesthesiology · 24d