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
88345–88368 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 21, 1998
ISOLA SPINAL SYSTEM
K980485 · MNI
Acromed Corp.
Orthopedic · 254d
Cleared Oct 21, 1998
VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH...
K980601 · JAQ
Varian Assoc., Inc.
Radiology · 246d
Cleared Oct 21, 1998
SLE EMG ELECTRODES AND ACCESSORIES
K981004 · IKT
Specialized Laboratory Equipment, Ltd.
Neurology · 217d
Cleared Oct 21, 1998
TFR
K981208 · JNM
Ramco Laboratories, Inc.
Immunology · 202d
Cleared Oct 21, 1998
MGB LAPALUX TELESCOPE
K982013 · GCJ
Mgb Endoskopische Gerate GmbH
General & Plastic Surgery · 135d
Cleared Oct 21, 1998
AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)
K982566 · EWO
Bar - Advanced Control Systems , Ltd.
Ear, Nose, Throat · 90d
Cleared Oct 21, 1998
NEUFINISH RESURFACING CREAM
K982577 · MGQ
Neutrogena Corp.
General & Plastic Surgery · 89d
Cleared Oct 21, 1998
DOCKING-EXTENSION WIRE
K982592 · DQX
Schneider (Europe) GmbH
Cardiovascular · 89d
Cleared Oct 21, 1998
ECHO-SCREEN
K982642 · EWO
Fischer-Zoth Audiologic Systems, Inc.
Ear, Nose, Throat · 84d
Cleared Oct 21, 1998
BIODERM FOAM WOUND DRESSING
K982778 · KMF
Bioderm, Inc.
General & Plastic Surgery · 75d
Cleared Oct 21, 1998
ASTEION CT SCANNER, TSX-021A
K982787 · JAK
Toshiba America Medical Systems, In.C
Radiology · 72d
Cleared Oct 21, 1998
HOSPAL TIPSTOP
K982818 · KMF
Gambro Healthcare
General & Plastic Surgery · 71d
Cleared Oct 21, 1998
RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE
K982862 · LLZ
Applicare Medical Imaging, B.V.
Radiology · 69d
Cleared Oct 21, 1998
ZETA MULTIZONE SCN LOCKING NAIL
K982873 · HSB
Howmedica Corp.
Orthopedic · 68d
Cleared Oct 21, 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9
K982896 · LDD
Alexander Mfg. Co.
Cardiovascular · 65d
Cleared Oct 21, 1998
SULZER ORTHOPEDICS FLUTED STEMS
K982903 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 64d
Cleared Oct 21, 1998
THREADED FIXATION PIN
K982931 · JDW
Sgarlato Laboratories, Inc.
Orthopedic · 62d
Cleared Oct 21, 1998
OSTEONICS EXTENDED FEMORAL BEARING HEAD
K982936 · LWJ
Osteonics Corp.
Orthopedic · 61d
Cleared Oct 21, 1998
TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES
K982953 · HSB
Biomet, Inc.
Orthopedic · 58d
Cleared Oct 21, 1998
ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS
K982984 · GEI
Microline Pentax, Inc.
General & Plastic Surgery · 56d
Cleared Oct 21, 1998
SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
K982987 · MNI
Synthes Spine
Orthopedic · 56d
Cleared Oct 21, 1998
TSRH SPINAL SYSTEM
K982990 · MNI
Sofamor Danek USA,Inc.
Orthopedic · 56d
Cleared Oct 21, 1998
ANSPACH ACCESS CRANIAL PERFORATOR
K982991 · HBF
The Anspach Effort, Inc.
Neurology · 55d
Cleared Oct 21, 1998
GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE
K982998 · JKA
Greiner Meditech, Inc.
Chemistry · 55d