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
73153–73176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 27, 2002
MIRAGE FULL FACE MASK SERIES 2
K023306 · BZD
Resmed, Ltd.
Anesthesiology · 55d
Cleared Nov 27, 2002
MODIFICATION TO RADIAL HEAD IMPLANT
K023604 · KWI
Avanta Orthopaedics, Inc.
Orthopedic · 30d
Cleared Nov 27, 2002
DATEX-OHMEDA HMEF MINI
K023641 · CAH
Datex-Ohmeda
General Hospital · 28d
Cleared Nov 27, 2002
CADENCE PEEK CEMEENT RESTRICTOR
K023647 · JDK
Spinal Concepts, Inc.
Orthopedic · 28d
Cleared Nov 27, 2002
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K023699 · LCX
Unipath , Ltd.
Chemistry · 23d
Cleared Nov 26, 2002
CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)
K013072 · MQV
Synthes
Orthopedic · 439d
Cleared Nov 26, 2002
RANDOX HAEMOGLOBIN A1C
K021897 · LCP
Randox Laboratories, Ltd.
Chemistry · 169d
Cleared Nov 26, 2002
SAFETOUCH
K022861 · NHM
Rusin Medical Devices
Obstetrics & Gynecology · 90d
Cleared Nov 26, 2002
INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022887 · KWH
Osteomed Corp.
Orthopedic · 88d