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
72889–72912 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 2003
CEM-OSTETIC BONE
K030266 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 24d
Cleared Feb 20, 2003
ACCOUSONIC PLUS, MODEL AP-170
K030410 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 13d
Cleared Feb 19, 2003
TRAVELAIR PORTABLE COMPRESSION SYSTEM
K022340 · JOW
Dynamic Air, Inc.
Cardiovascular · 216d
Cleared Feb 19, 2003
MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED)
K022814 · LZA
Pt. Smartglove Indonesia
General Hospital · 177d
Cleared Feb 19, 2003
THE BREATHE EZ ANTI-SNORING DEVICE
K022891 · LRK
D&S Redhage
Dental · 173d
Cleared Feb 19, 2003
MCPULSE
K023238 · JOM
Meridian Co., Ltd.
Cardiovascular · 145d
Cleared Feb 19, 2003
CVSI PERIPHERAL BALLOON CATHETER
K023463 · DQY
Cryo Vascular Systems, Inc.
Cardiovascular · 127d
Cleared Feb 19, 2003
ENDO-GLIDE GUIDEWIRE
K023603 · OCY
Endo-Therapeutics, Inc.
Gastroenterology & Urology · 114d
Cleared Feb 19, 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
K023882 · EZX
Implex Corp.
General & Plastic Surgery · 90d
Cleared Feb 19, 2003
PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM
K023906 · KPI
The Prometheus Group
Gastroenterology & Urology · 89d
Cleared Feb 19, 2003
SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
K024162 · CFF
Helena Laboratories
Immunology · 64d
Cleared Feb 19, 2003
PRECISION CAPILLARIES FOR MICROMANIPULATION
K024302 · MQH
Brinkmann Instruments, Inc.
Obstetrics & Gynecology · 57d
Cleared Feb 19, 2003
NEXUS INJECTION SITE (NIS), MODEL NIS-1
K024363 · FPA
Nexus Medical, LLC
General Hospital · 50d
Cleared Feb 19, 2003
MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, MMT-358M6,...
K030137 · FPA
Avail Medical Products, Inc.
General Hospital · 36d
Cleared Feb 19, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
K030148 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 35d
Cleared Feb 19, 2003
POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING...
K030157 · LYY
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 34d
Cleared Feb 19, 2003
BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY...
K030354 · EBD
Bisco, Inc.
Dental · 16d
Cleared Feb 14, 2003
EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS...
K022071 · DTM
Embol-X, Inc.
Cardiovascular · 233d
Cleared Feb 14, 2003
STEERABLE GUIDEWIRE
K022813 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 172d
Cleared Feb 14, 2003
RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO...
K023050 · IMG
Reliant Technologies, Inc.
Physical Medicine · 154d
Cleared Feb 14, 2003
ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR
K023407 · CGX
Elan Diagnostics
Chemistry · 127d
Cleared Feb 14, 2003
PLATELETWORKS, MODELS PW-A, PW-C
K023761 · JOZ
Helena Laboratories
Hematology · 98d
Cleared Feb 14, 2003
TAI-CHI AND MASTER ACUPUNCTURE NEEDLES
K023787 · MQX
Lhasa Medical, Inc.
General Hospital · 93d
Cleared Feb 14, 2003
ALBUMIN COBALT BINDING TEST (ACB TEST)
K023824 · NJV
Ischemia Technologies, Inc.
Chemistry · 88d