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
74617–74640 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 2002
NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120
K021760 · HAW
Orthosoft, Inc.
Neurology · 90d
Cleared Aug 27, 2002
PROTEIN S AC
K022290 · GGP
Dade Behring, Inc.
Hematology · 43d
Cleared Aug 27, 2002
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K022491 · JJX
Cliniqa Corporation
Chemistry · 29d
Cleared Aug 27, 2002
FONIX, MODEL 7000
K022510 · ETW
Frye Electronics, Inc.
Ear, Nose, Throat · 28d
Cleared Aug 27, 2002
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
K022550 · JBQ
Instrumentation Laboratory CO
Hematology · 25d
Cleared Aug 27, 2002
5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)
K022623 · KWP
Depuyacromed
Orthopedic · 20d
Cleared Aug 27, 2002
TAILWIND
K022704 · ITI
Deltaglide
Physical Medicine · 13d
Cleared Aug 26, 2002
LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2
K020529 · KFM
A-Med Systems, Inc.
Cardiovascular · 188d
Cleared Aug 26, 2002
REPHRESH VAGINAL GEL
K021737 · NUC
Columbia Laboratories, Inc.
Obstetrics & Gynecology · 90d
Cleared Aug 26, 2002
GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES...
K021777 · GEI
Gyrus Ent LLC
General & Plastic Surgery · 88d
Cleared Aug 26, 2002
BNF
K021782 · JDS
Aap Implantate AG
Orthopedic · 88d
Cleared Aug 26, 2002
TITANIUM ANKLE ARTHRODESIS NAIL
K021786 · HSB
Biomet, Inc.
Orthopedic · 88d
Cleared Aug 26, 2002
VERTE-STACK SPINAL SYSTEM
K021791 · MQP
Medtronic Sofamor Danek
Orthopedic · 87d
Cleared Aug 26, 2002
TEMPFIX EXTERNAL FIXATION SYSTEM
K021933 · KTT
DePuy Orthopaedics, Inc.
Orthopedic · 75d
Cleared Aug 26, 2002
CERANUM 87
K021947 · EJT
Lucius Metals Com.
Dental · 74d
Cleared Aug 26, 2002
ALLGRAD 45 AND 90 CELL SEPARATION MEDIA
K022330 · MQL
Intl., Inc.
Obstetrics & Gynecology · 39d
Cleared Aug 26, 2002
S2 TIBIAL NAIL
K022481 · HSB
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Aug 26, 2002
AART CALF IMPLANT
K022511 · MIB
Aesthetic and Reconstructive...
General & Plastic Surgery · 27d
Cleared Aug 26, 2002
POWDERED LATEX EXAM GLOVES WITH PROTEIN LABELING (200UG/G OR LESS)
K022530 · LYY
Hycare Intl. Co., Ltd.
General Hospital · 26d
Cleared Aug 26, 2002
2MM PEDIATRIC FLEX NAIL
K022531 · HTY
Biomet, Inc.
Orthopedic · 26d
Cleared Aug 26, 2002
ACCOLADE C FEMORAL STEMS
K022555 · LZO
Howmedica Osteonics Corp.
Orthopedic · 24d
Cleared Aug 26, 2002
POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL)
K022601 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 21d
Cleared Aug 26, 2002
MODIFICATION TO AVALON CUP SYSTEM
K022711 · LPH
Orthopedic Source, Inc.
Orthopedic · 12d
Cleared Aug 23, 2002
ENOXAPARIN TEST CARD
K013305 · KFF
Cardiovascular Diagnostics, Inc.
Hematology · 323d