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
74113–74136 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 23, 2002
ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE
K020220 · LFL
Synergetics, Inc.
General & Plastic Surgery · 213d
Cleared Aug 23, 2002
DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR
K020400 · GWF
Meps, LLC
Neurology · 198d
Cleared Aug 23, 2002
3T VESSEL CANNULAS
K020768 · DWF
3t Medical Systems, LLC
Cardiovascular · 169d
Cleared Aug 23, 2002
CHITO-SEAL
K021062 · QSY
Abbott Vascular, Inc.
General & Plastic Surgery · 143d
Cleared Aug 23, 2002
BCLEAR
K021762 · FTC
Lumenis, Inc.
General & Plastic Surgery · 86d
Cleared Aug 23, 2002
ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
K021819 · NBW
Lifescan, Inc.
Chemistry · 80d
Cleared Aug 23, 2002
BRAINET
K021986 · GXY
Nicolet Biomedical, Inc.
Neurology · 66d
Cleared Aug 23, 2002
BOLTON PTA CATHETER
K021996 · LIT
Bolton Medical, Inc.
Cardiovascular · 66d
Cleared Aug 23, 2002
SURGISIS STAPLE LINE REINFORCEMENT
K022044 · OXE
Cook Biotech, Inc.
General & Plastic Surgery · 60d