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
74785–74808 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 2002
MULTIVISION METHAFILCON A SOFT (HYDROPILIC) MULTIFOCAL LENS FOR DAILY WEAR
K021720 · LPL
Soflex Isralens Contact Lens , Ltd.
Ophthalmic · 80d
Cleared Aug 12, 2002
EBI DYNAFIX VS OSTEOTOMY SYSTEM
K021749 · NDF
Ebi, L.P.
Orthopedic · 76d
Cleared Aug 12, 2002
MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET...
K021902 · JQC
Medtronic Vascular
Hematology · 63d
Cleared Aug 12, 2002
MODIFICATION TO MEDSTATION
K021934 · LLZ
Aisoftw@Re Medical, S.P.A.
Radiology · 61d
Cleared Aug 12, 2002
FULCRUM
K021949 · LMA
Howtek, Inc.
Radiology · 60d
Cleared Aug 12, 2002
ALPHA INFUSION PUMP AND CATHETERS
K021964 · MEB
Advanced Infusion, Inc.
General Hospital · 59d
Cleared Aug 12, 2002
SYDNEY IVF CULTURE OIL
K022002 · MQL
Cook Urological, Inc.
Obstetrics & Gynecology · 54d
Cleared Aug 12, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K022172 · LON
Becton, Dickinson & CO
Microbiology · 40d
Cleared Aug 12, 2002
CADENCE CEMENT RESTRICTOR
K022218 · JDK
Spinal Concepts, Inc.
Orthopedic · 34d
Cleared Aug 12, 2002
HYDROBOOT
K022233 · DWL
Incappe, Inc.
General Hospital · 33d
Cleared Aug 12, 2002
EBI XFIX DFS SYSTEM
K022319 · KTT
Ebi, L.P.
Orthopedic · 26d
Cleared Aug 12, 2002
MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE
K022405 · GZJ
Rehabilicare, Inc.
Neurology · 27d
Cleared Aug 12, 2002
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K022419 · KWQ
Ebi, L.P.
Orthopedic · 19d
Cleared Aug 12, 2002
RAPID-FILL TUBESET, MODEL 90005
K022523 · LHI
Baxa Corp.
General Hospital · 13d
Cleared Aug 12, 2002
HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES
K022546 · EOQ
Horizons Intl. Corp.
Ear, Nose, Throat · 11d
Cleared Aug 09, 2002
FLEXLINE CLAMP
K010727 · DXC
Novare Surgical Systems, Inc.
Cardiovascular · 515d
Cleared Aug 09, 2002
LUMENIS SELECTA DUET
K021550 · GEX
Ellex Medical Pty, Ltd.
General & Plastic Surgery · 88d
Cleared Aug 09, 2002
SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW
K021556 · HWC
Synthes (Usa)
Orthopedic · 88d
Cleared Aug 09, 2002
NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE
K021578 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 87d
Cleared Aug 09, 2002
MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM
K021579 · HWC
Magly Orthopedics, LLC
Orthopedic · 87d
Cleared Aug 09, 2002
DURACLEAN WITH LYCRA POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE
K022095 · LZA
Wilshire Technologies
General Hospital · 43d
Cleared Aug 09, 2002
GIVEN DIAGNOSTICS SYSTEM
K022362 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 18d
Cleared Aug 08, 2002
URETERAL STENT
K013784 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 267d
Cleared Aug 08, 2002
BOYD DELIVERY UNIT
K020833 · EIA
Boyd Industries, Inc.
Dental · 147d