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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
9049–9072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 2023
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with...
K230681 · LZA
Central Medicare Sdn Bhd
General Hospital · 203d
Cleared Oct 02, 2023
Warantec Custom Abutment
K221972 · NHA
Warantec Co., Ltd.
Dental · 454d
Cleared Sep 30, 2023
Elecsys Tg II
K221890 · MSW
Roche Diagnostics
Immunology · 458d
Cleared Sep 29, 2023
3M™ Clarity™Aligners with Quick Attachments
K233257 · NXC
3M Company, Unitek Orthodontic Products
Dental · 1d
Cleared Sep 29, 2023
Guardenia (GAR-1)
K232701 · GCJ
Advanced Surgical Concepts
General & Plastic Surgery · 24d
Cleared Sep 29, 2023
Amulet™ Steerable Delivery Sheath
K232690 · DQY
Abbott Medical
Cardiovascular · 28d
Cleared Sep 29, 2023
TBI
K232669 · QAT
Abbott Laboratories
Immunology · 28d
Cleared Sep 29, 2023
BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter
K232651 · DRF
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Sep 29, 2023
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K232650 · NKB
S.M.A.I.O
Orthopedic · 29d
Cleared Sep 29, 2023
Microcatheter
K232647 · DQY
Surmodics,Inc.
Cardiovascular · 29d
Cleared Sep 29, 2023
CeraPutty
K232299 · KIF
Meta Biomed Co., Ltd.
Dental · 59d
Cleared Sep 29, 2023
PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove
K231973 · KGO
Ineo Tech Sdn Bhd
General Hospital · 88d
Cleared Sep 29, 2023
SafeBreak® Vascular
K231957 · QOI
Lineus Medical
General Hospital · 88d
Cleared Sep 29, 2023
WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible...
K231702 · FAJ
OTU Medical, Inc.
Gastroenterology & Urology · 109d
Cleared Sep 29, 2023
Intraosseous Fusion Device System
K231649 · HWC
Auxano Medical, LLC
Orthopedic · 115d
Cleared Sep 29, 2023
BeShape One™ Device
K231628 · OHV
Beshape Technologies , Ltd.
General & Plastic Surgery · 116d
Cleared Sep 29, 2023
REGER Nebulizer Irrigation Cannula
K231622 · GCJ
Reger Medizintechnik, GmbH
General & Plastic Surgery · 119d
Cleared Sep 29, 2023
TriALTIS Navigation Enabled Instruments
K231527 · OLO
Medos International S?rl
Orthopedic · 126d
Cleared Sep 29, 2023
Chemotherapy Gloves
K230847 · LZA
3A Glove Sdn. Bhd.
General Hospital · 185d
Cleared Sep 29, 2023
TriLEAP Plating System
K230591 · HRS
Crossroads Extremity Systems
Orthopedic · 210d
Cleared Sep 29, 2023
Terran NM-101
K230187 · LNH
Terran Biosciences, Inc.
Radiology · 249d
Cleared Sep 29, 2023
HipCheck
K230045 · QIH
Stryker Corp.
Radiology · 266d
Cleared Sep 29, 2023
Boppli Infant Blood Pressure Monitor
K223873 · DXN
Pyrames, Inc.
Cardiovascular · 280d
Cleared Sep 29, 2023
Miris Human Milk Analyzer (HMA)
K223085 · QEI
Miris AB
Chemistry · 364d