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
88297–88320 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 1998
BEGOCER G
K983082 · EJT
Bego U.S.A.
Dental · 56d
Cleared Oct 28, 1998
ELAN-2
K983091 · EBF
Kerr Dental Materials Center
Dental · 55d
Cleared Oct 28, 1998
MEPILEX
K983184 · MGP
Molnlycke Health Care, Inc.
General & Plastic Surgery · 47d
Cleared Oct 28, 1998
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1
K983709 · DIF
Beckman Coulter, Inc.
Toxicology · 7d
Cleared Oct 27, 1998
PIOLAX HYDROPHILIC GUIDEWIRE
K980977 · DQX
Piolax Medical Devices, Inc.
Cardiovascular · 225d
Cleared Oct 27, 1998
ELECSYS PSA, MODEL # ELECSYS 1010
K982948 · LTJ
Boehringer Mannheim Corp.
Immunology · 67d
Cleared Oct 27, 1998
ELECSYS PSA, MODEL 2010
K982949 · LTJ
Boehringer Mannheim Corp.
Immunology · 67d
Cleared Oct 27, 1998
SUMMIT ACETABULAR SYSTEM
K983014 · LPH
Johnson & Johnson Professionals, Inc.
Orthopedic · 60d
Cleared Oct 27, 1998
OSTEO DYNATROC PROXIMAL FEMORAL NAIL
K983339 · HSB
Osteonics Corp.
Orthopedic · 34d
Cleared Oct 27, 1998
CHEMSTRIP 101 URINE ANALYZER
K983510 · KQO
Boehringer Mannheim Corp.
Chemistry · 20d
Cleared Oct 27, 1998
FERRITIN CALIBRATOR
K983548 · JIT
Dade Behring, Inc.
Immunology · 18d
Cleared Oct 26, 1998
COBE SMARXT TUBING AND CONNECTORS
K981613 · DWE
Cobe Cardiovascular, Inc.
Cardiovascular · 173d
Cleared Oct 26, 1998
MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242
K982624 · IYE
Med-Tec,Inc.
Radiology · 90d
Cleared Oct 26, 1998
PATIENT WARMER- MODEL PW810
K982636 · ILY
Fisher &Paykel Healthcare , Ltd.
Physical Medicine · 89d
Cleared Oct 26, 1998
ADVANCED UROSCIENCE INJECTION NEEDLE
K982890 · FBK
Advanced Uroscience, Inc.
Gastroenterology & Urology · 70d
Cleared Oct 26, 1998
3M TEGASORB THIN HYDROCOLLOID DRESSING
K982892 · KMF
3M Company
General & Plastic Surgery · 70d
Cleared Oct 26, 1998
3M TEGASORB HYDROCOLLOID DRESSING
K982893 · KMF
3M Company
General & Plastic Surgery · 70d
Cleared Oct 26, 1998
SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM...
K983197 · KWP
United States Surgical, A Division of...
Orthopedic · 45d
Cleared Oct 26, 1998
DEPUY ACE COMPOSITE LOCKING NUT
K983265 · HTN
Depuy Ace Medical Co.
Orthopedic · 39d
Cleared Oct 25, 1998
ZIPPIE GS, MODEL # EIZGS
K983639 · IOR
Sunrise Medical, Inc.
Physical Medicine · 9d
Cleared Oct 23, 1998
MG
K981791 · JGJ
Abbott Laboratories
Chemistry · 155d
Cleared Oct 23, 1998
SHIKANI-FRENCH SPEAKING VALVE
K982128 · JOH
Pilling Weck Surgical
Anesthesiology · 128d
Cleared Oct 23, 1998
LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM
K982604 · MQN
Walter Lorenz Surgical, Inc.
Dental · 88d
Cleared Oct 23, 1998
WINSTATION RETINAL IMAGER
K982689 · HKI
Ophthalmic Imaging Systems
Ophthalmic · 81d