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
99265–99288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 25, 1996
KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS
K950999 · MNH
Buckman Co., Inc.
Orthopedic · 328d
Cleared Jan 25, 1996
SYSTEM ONE HYPERBARIC CHAMBER
K951044 · CBF
Nth Systems, Inc.
Anesthesiology · 324d
Cleared Jan 25, 1996
TECHNOFIL
K953748 · CAD
Technimeca Medic, Inc.
Anesthesiology · 167d
Cleared Jan 25, 1996
VIDEOSCOPE W/IRRIGATION SHEATH
K954016 · HRX
T. Korossurgical Instruments Corp.
Orthopedic · 153d
Cleared Jan 25, 1996
INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS
K954195 · GEX
Indigo Medical, Inc.
General & Plastic Surgery · 141d
Cleared Jan 25, 1996
BITE BLOCK
K954352 · JXL
United States Endoscopy Group, Inc.
Neurology · 129d
Cleared Jan 25, 1996
FIXANO I.F.O (INTERLOCKING FLEXIBLE OSTEOSYNTHESIS) SYSTEM
K954756 · HSB
Ferguson Medical
Orthopedic · 101d
Cleared Jan 25, 1996
FIXANO D.D.S. (DOUBLE SLIDING SCREW)
K954757 · HWC
Ferguson Medical
Orthopedic · 101d
Cleared Jan 25, 1996
CENTRA-LINE GRAPPLE, VARIFIX SYSTEM
K954770 · KWP
Advanced Spine Fixation Systems, Inc.
Orthopedic · 100d
Cleared Jan 25, 1996
TECHFIL
K954801 · CAD
Technimeca Medic, Inc.
Anesthesiology · 98d
Cleared Jan 25, 1996
BLOOD GAS MIXTURES
K954803 · BXK
Mittler Supply, Inc.
Anesthesiology · 98d
Cleared Jan 25, 1996
LUNG DIFFUSION MIXTURES
K954804 · BXK
Mittler Supply, Inc.
Anesthesiology · 98d
Cleared Jan 25, 1996
MEDPOR OCULAR SCREW & ACCESSORIES
K954939 · HPZ
Porex Surgical, Inc.
Ophthalmic · 87d
Cleared Jan 25, 1996
NATRACAREN APPLICATOR TAMPON
K954942 · HEB
Bodywise (Uk), Ltd.
Obstetrics & Gynecology · 87d
Cleared Jan 25, 1996
CEEGRAPH TRAVELER AMBULATORY EEG RECORDER
K954954 · GWQ
Bio-Logic Systems Corp.
Neurology · 87d
Cleared Jan 25, 1996
ROCHE COBAS INTEGRA REAGENT CASSETTES
K954992 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Jan 25, 1996
OLYMPUS FG SERIES GRASPING FORCEPS
K955066 · OCZ
Olympus America, Inc.
Gastroenterology & Urology · 80d
Cleared Jan 25, 1996
OPUS TROPONIN I
K955284 · MMI
Behring Diagnostics, Inc.
Chemistry · 70d
Cleared Jan 25, 1996
LACERATION TRAY
K955658 · FRG
Transidyne General Corp.
General Hospital · 44d
Cleared Jan 24, 1996
CONQUEROR, RUMBA AND TEMPTATION
K946207 · HIS
Frontline Latex Products Pvt. , Ltd.
Obstetrics & Gynecology · 399d
Cleared Jan 24, 1996
CARDIOLIPIN G EIA TEST SYSTEM
K946215 · MID
Hogan & Hartson
Immunology · 399d
Cleared Jan 24, 1996
CARDIOLIPIN A EIA TEST SYSTEM
K946216 · MID
Hogan & Hartson
Immunology · 399d
Cleared Jan 24, 1996
CARDIOLIPIN M EIA TEST SYSTEM
K946217 · MID
Hogan & Hartson
Immunology · 399d
Cleared Jan 24, 1996
TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS
K952557 · CDP
Sigma Diagnostics, Inc.
Chemistry · 236d