FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
123361–123384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 1991
PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE
K904947 · BZG
Planmeca USA, Inc.
Anesthesiology · 90d
Cleared Jan 30, 1991
PM2002 CC AND PM2002 EC
K904948 · EIA
Planmeca USA, Inc.
Dental · 90d
Cleared Jan 30, 1991
MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY
K904983 · EZN
Meadox Surgimed, Inc.
Gastroenterology & Urology · 89d
Cleared Jan 30, 1991
ACE 3.5MM CORTICAL BONE SCREW
K905048 · HWC
Ace Medical Co.
Orthopedic · 83d
Cleared Jan 30, 1991
LATEX GLOVE APPLICATION AND REMOVAL SYSTEM
K905127 · FMC
Success Builders Intl., Inc.
General Hospital · 77d
Cleared Jan 30, 1991
STAT(TM) GLOVE
K905177 · LZC
Success Builders Intl., Inc.
General Hospital · 72d
Cleared Jan 30, 1991
BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL)
K905189 · DQI
Baxter Healthcare Corp
General Hospital · 72d
Cleared Jan 30, 1991
TOTAL HIP FEMORAL COMPONENT
K905260 · LZO
Intermedics Orthopedics
Orthopedic · 70d
Cleared Jan 30, 1991
ADULT STAR, MODIFICATION
K905272 · CBK
Infrasonics Corp.
Anesthesiology · 68d
Cleared Jan 30, 1991
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
K905432 · DQX
Datascope Corp.
Cardiovascular · 57d
Cleared Jan 30, 1991
MERISTAR-MP
K905493 · GSA
Meridian Diagnostics, Inc.
Microbiology · 54d
Cleared Jan 30, 1991
RESPIRONICS BIPAP REMOTE CONTROL UNIT
K905540 · BZD
Respironics, Inc.
Anesthesiology · 50d
Cleared Jan 30, 1991
GAMMA-GLUTAMYL TRANSFERASE DETERMINATION
K905649 · JQB
Biochemical Trade, Inc.
Chemistry · 43d
Cleared Jan 30, 1991
LEAD STYLET
K905674 · DRB
Cardiac Pacemakers, Inc.
Cardiovascular · 43d
Cleared Jan 30, 1991
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K905773 · LIT
Mallinckrodt Medical
Cardiovascular · 34d
Cleared Jan 30, 1991
MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT
K905777 · CEE
Immunotech Corp.
Immunology · 34d
Cleared Jan 30, 1991
DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS
K905829 · CEL
Kamiya Biomedical Co.
Chemistry · 30d
Cleared Jan 30, 1991
SPECIFIC ALLERGEN MODULES FOR ALASTAT ALLERGEN IGE
K910075 · DHB
Diagnostic Products Corp.
Immunology · 22d
Cleared Jan 29, 1991
CEROS 80 (HA)
K900136 · LYC
Mathys Corp.
Dental · 384d
Cleared Jan 29, 1991
DEVICE PART NUMBER DPI-1106 IMPLANT
K902928 · DZE
Minimatic Implant Technology
Dental · 210d
Cleared Jan 29, 1991
TITANIUM COC ABUTMENT HEADS FOR IMZ
K904605 · DZE
Implant Support Systems, Inc.
Dental · 111d
Cleared Jan 29, 1991
MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE
K904745 · HGP
Graphic Controls Corp.
Obstetrics & Gynecology · 103d
Cleared Jan 29, 1991
ACOUSTIQ LISTENING DEVICE
K904755 · LZI
Krueger Laboratories
Ear, Nose, Throat · 102d
Cleared Jan 29, 1991
AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER*
K904931 · GAR
United States Surgical, A Division of...
General & Plastic Surgery · 90d