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
88777–88800 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 1998
JUMBO SILVER-REINFORCED GLASS IONOMER
K982665 · EMA
Centrix, Inc.
Dental · 46d
Cleared Sep 08, 1998
MIDAS TOUCH BIPOLAR FORCEPS
K982705 · GEI
Iti Medical Technologies, Inc.
General & Plastic Surgery · 36d
Cleared Sep 08, 1998
ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT
K982865 · NPK
Atrix Laboratories, Inc.
Dental · 26d
Cleared Sep 08, 1998
QUICK TAP SELF DRILLING SCREW
K982927 · DZL
Kinamed, Inc.
Dental · 19d
Cleared Sep 04, 1998
BIOSENSORS EMBOLECTOMY CATHETER
K973477 · DXE
Sunscope Intl., Inc.
Cardiovascular · 354d
Cleared Sep 04, 1998
FRIALIT-2 CORABASE
K980630 · DZE
Friatec AG
Dental · 198d
Cleared Sep 04, 1998
EVITA 4 (8411900)
K980642 · CBK
Drager, Inc.
Anesthesiology · 197d
Cleared Sep 04, 1998
HEARTPORT ENDOPULMONARY VENT CATHETER
K981009 · DWF
Heartport, Inc.
Cardiovascular · 170d
Cleared Sep 04, 1998
VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE
K981314 · DJR
Sun Biomedical Laboratories, Inc.
Chemistry · 147d
Cleared Sep 04, 1998
ALBATECH PERSONAL MONITOR
K981999 · GCJ
Albatech, Inc.
General & Plastic Surgery · 88d
Cleared Sep 04, 1998
STOCKERT COMPACT SYSTEM
K982014 · DTQ
Stoeckert Instrumente
Cardiovascular · 88d
Cleared Sep 04, 1998
PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT
K982023 · DAS
Inova Diagnostics, Inc.
Immunology · 87d
Cleared Sep 04, 1998
HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100...
K982025 · MKJ
Hewlett-Packard Co.
Cardiovascular · 87d
Cleared Sep 04, 1998
AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM
K982088 · DZB
Ortho Kinetics Corp.
Dental · 81d
Cleared Sep 04, 1998
SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5...
K982102 · MEB
Baxter Healthcare Corp
General Hospital · 81d
Cleared Sep 04, 1998
FLUID CONTROL
K982117 · EIA
T.A. Coleman Ent.
Dental · 80d
Cleared Sep 04, 1998
FLOW 7000 PERIPHERAL VASCULAR COIL
K982339 · MOS
Usa Instruments, Inc.
Radiology · 60d
Cleared Sep 04, 1998
NIM4
K982595 · ETN
Xomed, Inc.
Ear, Nose, Throat · 39d
Cleared Sep 04, 1998
COLLEAGUE PUMP SYRINGE ADAPTER SET
K982672 · FPA
Baxter Healthcare Corp
General Hospital · 35d
Cleared Sep 04, 1998
MODIFICATION TO ALLIGER ULTRASONIC SURGICAL SYSTEM, MODEL AUSS-4
K982841 · LFL
Misonix, Inc.
General & Plastic Surgery · 23d
Cleared Sep 04, 1998
MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER
K982883 · DQY
Medtronics Interventional Vascular
Cardiovascular · 18d
Cleared Sep 03, 1998
N-ASSAY GLU-UL
K980883 · CFR
Crestat Diagnostics, Inc.
Chemistry · 178d
Cleared Sep 03, 1998
SYSTEM U3 FOR CIPROFLOXACIN
K981639 · JWY
Ab Biodisk
Microbiology · 118d
Cleared Sep 03, 1998
BINDAZYME ANTIGLIADIN IGG
K981644 · MST
The Binding Site, Ltd.
Immunology · 118d