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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
127705–127728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 1990
BIVONA CARDEN INTERMITTENT JETTING DEVICE
K895946 · BTL
Bivona Medical Technologies
Anesthesiology · 90d
Cleared Jan 09, 1990
KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS
K895962 · JWH
Kirschner Medical Corp.
Orthopedic · 90d
Cleared Jan 09, 1990
ACUSOURCE 600 (TENS)
K895977 · GZJ
Microcurrent Research, Inc.
Neurology · 89d
Cleared Jan 09, 1990
THE PILOT SCIMED TORQUE DEVICE
K896108 · LOX
Scimed Life Systems, Inc.
Cardiovascular · 78d
Cleared Jan 09, 1990
SCHILLER MODEL SP-100 SPIROVIT(TM)
K896120 · BZG
Schiller America, Inc.
Anesthesiology · 77d
Cleared Jan 09, 1990
SCHILLER MODEL SP-200 SPIROVIT(TM)
K896121 · BZG
Schiller America, Inc.
Anesthesiology · 77d
Cleared Jan 09, 1990
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR
K896128 · CAN
Puritan Bennett Corp.
Anesthesiology · 78d
Cleared Jan 09, 1990
INFANT C.P.A.P. MONITOR
K896136 · CAP
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 78d
Cleared Jan 09, 1990
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW.
K896152 · CAN
Puritan Bennett Corp.
Anesthesiology · 77d
Cleared Jan 09, 1990
APT TRACHEA TUBES
K896181 · BTR
Advanced Pulmonary Technologies, Inc.
Anesthesiology · 76d
Cleared Jan 09, 1990
TUBING FLEXIBLE MEDICAL GAS LOW-PRESSURE
K896439 · BZO
Ventlab Corp.
Anesthesiology · 61d
Cleared Jan 09, 1990
RATE INCREASE FOR IPPB/IPV
K896586 · DZD
Percussionaire Corp.
Dental · 48d
Cleared Jan 09, 1990
LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE
K896595 · GEX
Luxar Corp.
General & Plastic Surgery · 49d
Cleared Jan 09, 1990
S.A.F. ACETABULAR CUP WITH POROUS COATING
K896614 · JDL
Synergy Orthopaedics Intl., Inc.
Orthopedic · 49d
Cleared Jan 09, 1990
LISTING ENT AS INTENDED USE FOR ENDOGUIDE
K896617 · GEX
Luxar Corp.
General & Plastic Surgery · 49d
Cleared Jan 09, 1990
LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE
K896618 · GEX
Luxar Corp.
General & Plastic Surgery · 49d
Cleared Jan 09, 1990
LIST DERMATOLOGY/PLASTIC SURGERY AS USE ENDOGUIDE
K896619 · GEX
Luxar Corp.
General & Plastic Surgery · 49d
Cleared Jan 09, 1990
LISTING PODIATRY AS INTENDED USE FOR ENDOGUIDE
K896711 · GEX
Luxar Corp.
General & Plastic Surgery · 42d
Cleared Jan 09, 1990
CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU.
K896724 · GEH
Stiefel Research Institute, Inc.
General & Plastic Surgery · 41d
Cleared Jan 08, 1990
MODEL DS-3300 DYNASCOPE PATIENT MONITOR
K894628 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 168d
Cleared Jan 08, 1990
MULES SPHERE GLASS (SEVERAL SIZES)
K895908 · HPZ
Ginsberg Scientific, Inc.
Ophthalmic · 90d
Cleared Jan 08, 1990
INAMED CLOSED-WOUND DRAIN SYSTEM
K896491 · GCY
Inamed Development Co.
General & Plastic Surgery · 56d
Cleared Jan 08, 1990
MENSTRUAL TAMPON
K897008 · HEB
Personal Products Co.
Obstetrics & Gynecology · 19d
Cleared Jan 05, 1990
MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER
K881263 · HGL
Multigon Industries, Inc.
Obstetrics & Gynecology · 652d