Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
82777–82800 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 2000
ACULUX, MODEL AX3001, AX3002
K001223 · FQP
Aculux
General & Plastic Surgery · 67d
Cleared Jun 23, 2000
LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING...
K001274 · KGO
Pt. Maja Agung Latexindo
General Hospital · 64d
Cleared Jun 23, 2000
TRIFLANGE ACETABULAR CUP SYSTEM
K001277 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 63d
Cleared Jun 23, 2000
PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP
K001299 · GAL
Cp Medical
General & Plastic Surgery · 60d
Cleared Jun 23, 2000
PALCERAM 49
K001481 · EJT
Aurex SA (Pty) , Ltd.
Dental · 43d
Cleared Jun 23, 2000
AURENORM 75 KF
K001482 · EJT
Aurex SA (Pty) , Ltd.
Dental · 43d
Cleared Jun 23, 2000
DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES
K001601 · LYZ
Shanghai PT Plastics Enterprise...
General Hospital · 30d
Cleared Jun 23, 2000
DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR
K001637 · LZA
Sheen More Ent. Co., Ltd.
General Hospital · 24d
Cleared Jun 23, 2000
BIOSOFT RESIN
K001640 · EBI
Biosoft International Corp.
Dental · 46d
Cleared Jun 23, 2000
VARIS 1.4G
K001643 · IYE
Varian Medical Systems, Inc.
Radiology · 24d
Cleared Jun 23, 2000
STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234
K001649 · JOJ
Steritec Products, Inc.
General Hospital · 24d
Cleared Jun 23, 2000
RESOLVE SURGICAL O.R. TOWELS
K001667 · KKX
Allegiance Healthcare Corp.
General Hospital · 23d
Cleared Jun 23, 2000
POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES
K001672 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 22d
Cleared Jun 23, 2000
GALILEO VENTILATOR
K001686 · CBK
Hamilton Medical, Inc.
Anesthesiology · 36d
Cleared Jun 23, 2000
GEMINI E
K993623 · DQD
Allen Medical Instruments Corp.
Cardiovascular · 241d
Cleared Jun 23, 2000
FIRST CHECK HOME DRUG TEST (THC)
K993663 · LDJ
Worldwide Medical Corp.
Toxicology · 238d
Cleared Jun 23, 2000
FIRST CHECK HOME DRUG TEST PANEL 3
K994138 · LDJ
Worldwide Medical Corp.
Toxicology · 199d
Cleared Jun 23, 2000
FIRST CHECK HOME DRUG TEST PANEL 2
K994139 · LDJ
Worldwide Medical Corp.
Toxicology · 199d
Cleared Jun 23, 2000
IL TEST LIQUID ANTITHROMBIN
K994238 · JBQ
Instrumentation Laboratory CO
Hematology · 190d
Cleared Jun 22, 2000
CRITERION 60 OR PM 60
K000959 · CAP
Caradyne, Ltd.
Anesthesiology · 90d
Cleared Jun 22, 2000
ANATOMIC TOTAL KNEE PROSTHESIS
K000978 · JWH
Biomet, Inc.
Orthopedic · 87d
Cleared Jun 22, 2000
BIPAP DUET LX BI-LEVEL SYSTEM
K000994 · BZD
Respironics, Inc.
Anesthesiology · 86d
Cleared Jun 22, 2000
CD HORIZON ECLIPSE
K001066 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 80d
Cleared Jun 22, 2000
ULTRASIM CT SYSTEM
K001088 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 79d