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
73657–73680 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 2002
KSEA SPINOSCOPE
K023187 · HRX
Karl Storz Endoscopy
Orthopedic · 69d
Cleared Dec 02, 2002
CYNOVAD ZIRKON
K023327 · EIH
Cynovad
Dental · 59d
Cleared Dec 02, 2002
EXPLORER POWERED WHEELCHAIR
K023485 · ITI
Evermed Corp.
Physical Medicine · 46d
Cleared Dec 02, 2002
TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION...
K023514 · QEY
Bacchus Vascular, Inc.
Cardiovascular · 42d
Cleared Dec 02, 2002
DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE
K023517 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 45d
Cleared Dec 02, 2002
EVLT KIT AND D15PLUS AND D30PLUS DIODE
K023543 · GEX
Diomed, Inc.
General & Plastic Surgery · 41d
Cleared Dec 02, 2002
COMFORT AGILE SCOOTER, LY-EW303
K023581 · INI
Comfort Orthopedic Co., Ltd.
Physical Medicine · 39d
Cleared Nov 29, 2002
ELECSYS PROBNP CALCHECK
K020883 · JJX
Roche Diagnostics Corp.
Chemistry · 256d
Cleared Nov 29, 2002
INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST
K022915 · JXN
Alfa Scientific Designs, Inc.
Chemistry · 87d
Cleared Nov 29, 2002
EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES, BLUE COLOR
K023522 · LYY
Ever-More Latex Products Sdn Bhd
General Hospital · 39d
Cleared Nov 29, 2002
EVER-MORE POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES
K023523 · LYY
Ever-More Latex Products Sdn Bhd
General Hospital · 39d
Cleared Nov 29, 2002
EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES
K023524 · LYY
Ever-More Latex Products Sdn Bhd
General Hospital · 39d
Cleared Nov 29, 2002
PHILIPS DRUG CALCULATOR SOFTWARE
K023674 · MHX
Philips Medical Systems
Cardiovascular · 28d
Cleared Nov 29, 2002
STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
K023765 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 17d
Cleared Nov 29, 2002
UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES
K023767 · GEI
The Olympus Optical Co.
General & Plastic Surgery · 17d
Cleared Nov 29, 2002
NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N: 20193-084 AND...
K023812 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 14d
Cleared Nov 27, 2002
ENDOVASCULAR GUIDE WIRE
K021363 · DQX
Stereotaxis, Inc.
Cardiovascular · 211d
Cleared Nov 27, 2002
RECOVERY FILTER SYSTEM, MODEL RF-048F
K022236 · DTK
C.R. Bard, Inc.
Cardiovascular · 139d
Cleared Nov 27, 2002
CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
K022329 · LTK
Bayer Diagnostics Corp.
Immunology · 132d
Cleared Nov 27, 2002
CHILLBUSTER
K022903 · DWJ
Microtek Medical, Inc.
Cardiovascular · 85d
Cleared Nov 27, 2002
ADAPTERS WITH X-COATING
K022918 · DTL
Terumo Cardiovascular Systems...
Cardiovascular · 84d
Cleared Nov 27, 2002
STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C
K022977 · DAP
Dade Behring, Inc.
Hematology · 82d
Cleared Nov 27, 2002
MIRAGE FULL FACE MASK SERIES 2
K023244 · BZD
Resmed, Ltd.
Anesthesiology · 58d
Cleared Nov 27, 2002
MIRAGE FULL FACE MASK SERIES 2
K023284 · BZD
Resmed, Ltd.
Anesthesiology · 56d