FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
85585–85608 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 1999
METRA PS PROCEDURE KIT
K984600 · GCJ
Inlet Medical, Inc.
General & Plastic Surgery · 157d
Cleared Jun 03, 1999
AIA-PACK CA 125
K990431 · LTK
Tosoh Medics, Inc.
Immunology · 112d
Cleared Jun 03, 1999
LAMITRODE LEADS
K990469 · GZB
Advanced Neuromodulation Systems
Neurology · 107d
Cleared Jun 03, 1999
RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777
K990483 · DTB
Biotronik, Inc.
Cardiovascular · 107d
Cleared Jun 03, 1999
POWDER FREE BLUE NITRILE GLOVE
K990668 · LZA
Tg Medical Sdn. Bhd.
General Hospital · 93d
Cleared Jun 03, 1999
THERMAL CAUTERY DEVICE, FORCEPS
K990728 · HQP
Starion Instruments
Ophthalmic · 90d
Cleared Jun 03, 1999
INSIGHT MILLENNIUM
K990778 · HCC
Fasstech
Neurology · 86d
Cleared Jun 03, 1999
COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS
K990815 · LPL
Colorsoft Laboratories Corp.
Ophthalmic · 84d
Cleared Jun 03, 1999
AUTODOSE INFUSION SYSTEM
K990889 · MEB
Tandem Medical, Inc.
General Hospital · 78d
Cleared Jun 03, 1999
MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS
K990910 · HIH
Mtp Medical Technical Promotion GmbH
Obstetrics & Gynecology · 77d
Cleared Jun 03, 1999
MTP ARTHROPUMP DISPOSABLE TUBING SET
K990911 · HRX
Mtp Medical Technical Promotion GmbH
Orthopedic · 77d
Cleared Jun 03, 1999
ORTHOGONAL EP CATHETERS
K990958 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 73d
Cleared Jun 03, 1999
KSEA NEURO-FIBERSCOPE
K991069 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 64d
Cleared Jun 03, 1999
STERIS SMOKE EVACUATION SYSTEM
K991167 · FYD
STERIS Corporation
General Hospital · 57d
Cleared Jun 03, 1999
LC MICROFILL
K991442 · EBF
S & C Polymer GmbH
Dental · 38d
Cleared Jun 03, 1999
UNI-CLIP STAPLE
K991482 · JDR
New Deal, S.A.
Orthopedic · 36d
Cleared Jun 03, 1999
POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)
K991511 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 34d
Cleared Jun 03, 1999
OPERA CUPFLANGED ACETABULAR COMPONENTS
K991538 · JDI
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 31d
Cleared Jun 03, 1999
SMARTSPOT 2000
K991578 · LLZ
Cmt Medical Technologies, Ltd.
Radiology · 28d
Cleared Jun 03, 1999
SOFTINJECT
K991680 · KZH
Androsystems Srl
General Hospital · 17d
Cleared Jun 03, 1999
SSA-370A/POWERVISION 6000
K991710 · IYO
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Jun 02, 1999
AILEE SUTURES AND AILEE NEEDLES
K982646 · GAL
Myco Medical Supplies, Inc.
General & Plastic Surgery · 308d
Cleared Jun 02, 1999
INTRACOIL PERIPHERAL STENT
K990221 · JCT
Intratherapeutics, Inc.
General & Plastic Surgery · 131d
Cleared Jun 02, 1999
THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY
K990658 · JLW
Little Nell Labs, Inc.
Chemistry · 93d