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
77161–77184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 2001
OXYGENATOR
K002632 · KPJ
Adjunctive Therapeutics, Inc.
General & Plastic Surgery · 428d
Cleared Oct 25, 2001
AUTOPULSE, MODEL 100
K011046 · DRM
Revivant Corp.
Cardiovascular · 202d
Cleared Oct 25, 2001
VENODYNE DVT ADVANTAGE PLUS
K011318 · JOW
Microtek Medical, Inc.
Cardiovascular · 177d
Cleared Oct 25, 2001
DRUGS OF ABUSE MULTI-TEST STRIP
K011952 · DKZ
Microdiagnostics, Inc.
Toxicology · 126d
Cleared Oct 25, 2001
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
K012141 · DRN
External Counterpulsation Lab
Cardiovascular · 107d
Cleared Oct 25, 2001
ARTHROCARE ELECTROSURGERY WANDS
K012519 · GEI
Arthrocare Corp.
General & Plastic Surgery · 80d
Cleared Oct 25, 2001
LIFE 2
K012717 · EJK
Sybron Dental Specialties, Inc.
Dental · 71d
Cleared Oct 25, 2001
MONOJECT SAFETY NEEDLE
K012736 · FMI
Tyco Healthcare
General Hospital · 70d
Cleared Oct 25, 2001
MACROPORE ENT RECONSTRUCTION FILM
K012769 · NHB
Macropore Biosurgery, Inc.
Ear, Nose, Throat · 69d
Cleared Oct 25, 2001
WINNER CM4 COMBINATION UNIT
K012848 · GZJ
Rich-Mar Corp.
Neurology · 63d
Cleared Oct 25, 2001
COLLATEK SHEET
K012995 · MGP
Biocore Medical Technologies, Inc.
General & Plastic Surgery · 49d
Cleared Oct 25, 2001
COLLATEK FOAM
K012997 · MGP
Biocore Medical Technologies, Inc.
General & Plastic Surgery · 49d
Cleared Oct 25, 2001
CERCON BASE
K013230 · EIH
Degussa - Ney Dental, Inc.
Dental · 28d
Cleared Oct 25, 2001
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
K013272 · KLS
Bayer Corp.
Chemistry · 24d
Cleared Oct 24, 2001
EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188
K000741 · IPF
138 Medical Supplies, Inc.
Physical Medicine · 596d
Cleared Oct 24, 2001
EZ-ON CONDOM
K001974 · MOL
Mayer Laboratories
Obstetrics & Gynecology · 482d
Cleared Oct 24, 2001
LIFT VB SPINAL SYSTEM
K010930 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 210d
Cleared Oct 24, 2001
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD
K011056 · QEW
Arrow Intl., Inc.
Cardiovascular · 201d
Cleared Oct 24, 2001
SECUREGUARD RETRACTABLE SAFETY SYRINGE
K012121 · MEG
Safegard Medical Products, Inc.
General Hospital · 110d
Cleared Oct 24, 2001
24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524
K012143 · DRA
Medtronic Cardiac Surgical Products
Cardiovascular · 106d
Cleared Oct 24, 2001
CONFORM SHEETING, MODEL IGEL
K012419 · MDA
Implantech Associates, Inc.
General & Plastic Surgery · 86d
Cleared Oct 24, 2001
CAAS II QVA
K012475 · LLZ
Pie Medical Imaging BV
Radiology · 83d
Cleared Oct 24, 2001
MACHNET CAROTIDS COIL ARRAY ASSEMBLY
K012491 · MOS
Machnet BV
Radiology · 82d
Cleared Oct 24, 2001
PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM
K012673 · DYH
Prime Dental Manufacturing, Inc.
Dental · 71d