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
83569–83592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 1999
DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)
K990849 · LPH
Howmedica Osteonics Corp.
Orthopedic · 280d
Cleared Dec 20, 1999
POLLER CALIBRANTS
K991439 · GGN
European Concerted Action on...
Hematology · 238d
Cleared Dec 20, 1999
HANG UPS POWER II
K991835 · ITH
Stl Intl., Inc.
Physical Medicine · 206d
Cleared Dec 20, 1999
EIS THREADED SCREW FRACTURE FIXATION
K991964 · HWC
Groupe Lepine
Orthopedic · 193d
Cleared Dec 20, 1999
EMBOLIZATION COIL SYSTEM
K992121 · KRD
Cook, Inc.
Cardiovascular · 180d
Cleared Dec 20, 1999
LACTOSORB TRAUMA PLATING SYSTEM
K992355 · HRS
Biomet, Inc.
Orthopedic · 159d
Cleared Dec 20, 1999
ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA...
K992531 · JOZ
Accumetrics, Inc.
Hematology · 145d
Cleared Dec 20, 1999
INTERFACE MODULE IDDD
K992635 · KRI
Stoeckert Instrumente
Cardiovascular · 136d
Cleared Dec 20, 1999
ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST
K993048 · PSZ
Roche Diagnostics Corp.
Microbiology · 101d
Cleared Dec 20, 1999
PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR
K993096 · CHH
Lifestream Technologies, Inc.
Chemistry · 206d
Cleared Dec 20, 1999
MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
K993169 · DRG
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Dec 20, 1999
SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM
K993289 · KTT
Smith & Nephew, Inc.
Orthopedic · 80d
Cleared Dec 20, 1999
SADDLE SHAPED PATELLA
K993371 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 74d
Cleared Dec 20, 1999
CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER
K993375 · KRX
Clinical Diagnostic Solutions, Inc.
Hematology · 74d
Cleared Dec 20, 1999
LATEX EXAMINATION POWDERED GLOVES
K993386 · LYY
Great Glove Sdn Bhd
General Hospital · 73d
Cleared Dec 20, 1999
OPUS SPINAL SYSTEM
K993402 · MNI
Howmedica Osteonics Corp.
Orthopedic · 73d
Cleared Dec 20, 1999
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46
K993432 · DXN
Rossmax International , Ltd.
Cardiovascular · 69d
Cleared Dec 20, 1999
BIRD V.I.P. GOLD/STERLING
K993449 · CBK
Bird Products Corp.
Anesthesiology · 69d
Cleared Dec 20, 1999
GREEN POWDERED LATEX EXAMINATION GLOVES
K993452 · LYY
Top Glove Sdn. Bhd.
General Hospital · 68d
Cleared Dec 20, 1999
PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES
K993605 · LYY
Top Glove Sdn. Bhd.
General Hospital · 56d
Cleared Dec 20, 1999
LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20
K993668 · BTA
Laerdal Medical A/S
General & Plastic Surgery · 49d
Cleared Dec 20, 1999
ALATECH LATEX CONDOM
K993887 · HIS
Alatech Healthcare, LLC
Obstetrics & Gynecology · 34d
Cleared Dec 20, 1999
A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS
K993888 · DXN
A&D Engineering, Inc.
Cardiovascular · 34d
Cleared Dec 20, 1999
TITANIUM PEDIATRIC FEMORAL NAIL
K993956 · HSB
Biomet, Inc.
Orthopedic · 28d