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
78073–78096 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 2001
OPUS MAGNUM ANCHOR & INSERTER
K012125 · HTY
Opus Medical, Inc.
Orthopedic · 73d
Cleared Sep 17, 2001
ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP
K012300 · JXM
ACON Laboratories, Inc.
Toxicology · 59d
Cleared Sep 17, 2001
POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN...
K012558 · LYY
Matang Mfg. Sdn. Bhd.
General Hospital · 40d
Cleared Sep 17, 2001
MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
K012898 · DTR
Cobe Cardiovascular, Inc.
Cardiovascular · 19d
Cleared Sep 14, 2001
COPELAND MB RESURFACING HUMERAL HEADS
K010657 · HSD
Biomet Manufacturing, Inc.
Orthopedic · 192d
Cleared Sep 14, 2001
COPELAND MB/HA RESURFACING HUMERAL HEADS
K010827 · HSD
Biomet Orthopedics, Inc.
Orthopedic · 178d
Cleared Sep 14, 2001
VERTEX ETCHANT
K010849 · EBF
Apex Dental Materials, Inc.
Dental · 177d
Cleared Sep 14, 2001
E-STETH ELECTRONIC STETHOSCOPE
K011898 · DQD
E-Med Innovations, Inc.
Cardiovascular · 88d
Cleared Sep 14, 2001
ALLERSHARP ALLERGY SKIN TESTER
K011979 · SCL
Hmb Medical Concepts, Ltd.
General Hospital · 81d
Cleared Sep 14, 2001
BANDVIEW SYSTEM
K012103 · LNJ
Applied Spectral Imaging , Ltd.
Pathology · 71d
Cleared Sep 14, 2001
ACTICLOT PROTEIN S, MODEL 843L
K012386 · GGP
American Diagnostica, Inc.
Hematology · 49d
Cleared Sep 14, 2001
BIOTEQUE SCALP VEIN SET
K012526 · FPA
Bioteque Corp.
General Hospital · 39d
Cleared Sep 14, 2001
CARIES DETECTOR
K012733 · LFC
Kuraray Medical, Inc.
Dental · 31d
Cleared Sep 14, 2001
CLEARFIL NEW BOND
K012734 · KLE
Kuraray Medical, Inc.
Dental · 31d
Cleared Sep 14, 2001
CLEARFIL DC CEMENT
K012735 · EMA
Kuraray Medical, Inc.
Dental · 31d
Cleared Sep 14, 2001
CHROMA ZONE COLOR STAIN
K012737 · EBF
Kuraray Medical, Inc.
Dental · 31d
Cleared Sep 14, 2001
CLEARFIL AP-X
K012740 · EBF
Kuraray Medical, Inc.
Dental · 31d
Cleared Sep 14, 2001
TEETHMATE F-1
K012742 · EBC
Kuraray Medical, Inc.
Dental · 31d
Cleared Sep 14, 2001
TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T
K012743 · DRY
Medtronic Perfusion Systems
Cardiovascular · 29d
Cleared Sep 14, 2001
TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)
K012747 · DPT
Medtronic Perfusion Systems
Cardiovascular · 29d
Cleared Sep 14, 2001
MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
K012837 · MLD
Datex-Ohmeda
Cardiovascular · 22d
Cleared Sep 14, 2001
SIMPLICITY SOFT QD MICRO INFUSION SET
K012845 · FPA
Sterling Medivations, Inc.
General Hospital · 22d
Cleared Sep 13, 2001
COLORMATE TLC BILITEST SYSTEM
K001687 · MQM
Chromatics Color Sciences Intl., Inc.
Chemistry · 469d
Cleared Sep 13, 2001
EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K011240 · NBW
Medline Industries, Inc.
Chemistry · 143d