Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
46873–46896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2011
SONOLITH I-MOVE
K111808 · LNS
Edap Tms France
Gastroenterology & Urology · 35d
Cleared Jul 29, 2011
PAIN BUDDY
K102051 · NUH
Biomedical Life Systems, Inc.
Neurology · 373d
Cleared Jul 29, 2011
VOYAGER PERITONEAL DIALYSIS SYSTEM
K103220 · FKX
Deka Research & Development Corp.
Gastroenterology & Urology · 270d
Cleared Jul 29, 2011
SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
K103740 · NGT
Spectra Medical Devices, Inc.
General Hospital · 219d
Cleared Jul 29, 2011
JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)
K103830 · FMF
Jiangsu Shenli Medical Production...
General Hospital · 211d
Cleared Jul 29, 2011
PE-210AK SWITCH BOX
K110376 · GWQ
Nihon Kohden Corp.
Neurology · 170d
Cleared Jul 29, 2011
ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR
K110390 · GZJ
Handelshaus Dittman GmbH
Neurology · 168d
Cleared Jul 29, 2011
OSI O-BALL ABUTMENT HEAD IMPLANTS
K110548 · DZE
Juell Dental
Dental · 154d
Cleared Jul 29, 2011
COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN
K110600 · NPL
Collagen Matrix, Inc.
Dental · 149d
Cleared Jul 29, 2011
BIODENTA CUSTOMIZED ABUTMENT
K110778 · NHA
Biodenta Swiss AG
Dental · 130d
Cleared Jul 29, 2011
HEARTNAVIGATOR RELEASE 1
K111245 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 87d
Cleared Jul 29, 2011
VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH
K111424 · FMI
Medpro Safety Products, Inc.
General Hospital · 67d
Cleared Jul 29, 2011
MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL...
K111529 · KNW
Insert Molding Solutions, Inc.
Gastroenterology & Urology · 57d
Cleared Jul 29, 2011
GLIDECROSS SUPPORT CATHETER
K111556 · DQY
Terumo Medical Corp.
Cardiovascular · 53d
Cleared Jul 29, 2011
ENDOMAXX FULLY COVERED ESOPHAGEAL STENT
K111611 · ESW
Merit Medical Systems, Inc.
Gastroenterology & Urology · 50d
Cleared Jul 29, 2011
AMSCO WARMING CABINET
K111870 · LGZ
STERIS Corporation
General Hospital · 28d
Cleared Jul 29, 2011
OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME
K111884 · MGZ
LeMaitre Vascular, Inc.
Cardiovascular · 28d
Cleared Jul 29, 2011
XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY
K111906 · LJS
Navilyst Medical, Inc.
General Hospital · 24d
Cleared Jul 28, 2011
N-FORCE FIXATION SYSTEM
K102528 · HWC
Innovision, Inc.
Orthopedic · 328d
Cleared Jul 28, 2011
XELIS 3D
K103130 · LLZ
Infinitt Co., Ltd.
Radiology · 279d
Cleared Jul 28, 2011
PREGNANCY ONE STEP RAPID TEST
K103574 · LCX
Lehnus & Associates Consulting
Chemistry · 234d
Cleared Jul 28, 2011
ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY...
K110261 · LPL
Soflex Limited
Ophthalmic · 181d
Cleared Jul 28, 2011
AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
K110419 · GXZ
Stryker Spine
Neurology · 164d
Cleared Jul 28, 2011
TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS,...
K110571 · NBW
Telcare, Inc.
Chemistry · 149d