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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
54481–54504 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 2009
MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON
K090098 · HEB
Maxim Hygiene Products, Inc.
Obstetrics & Gynecology · 15d
Cleared Jan 29, 2009
I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE...
K073593 · DPT
Deltex Medical Limited
Cardiovascular · 405d
Cleared Jan 29, 2009
ANTERIOR BUTTRESS PLATE
K081548 · KWQ
Scient'X USA, Inc.
Orthopedic · 241d
Cleared Jan 29, 2009
MAICO MB 11 WITH BERAPHONE PROBE
K082035 · GWJ
Maico-Diagnostics
Neurology · 196d
Cleared Jan 29, 2009
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML
K082852 · LON
Becton, Dickinson & CO
Microbiology · 122d
Cleared Jan 29, 2009
STER-MATE STERILE LAVAGE KIT
K082973 · ELC
Dentsply Interntional
Dental · 115d
Cleared Jan 29, 2009
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961
K083246 · DXN
Andon Health Co, Ltd.
Cardiovascular · 87d
Cleared Jan 29, 2009
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906
K083247 · DXN
Andon Health Co, Ltd.
Cardiovascular · 87d
Cleared Jan 29, 2009
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902
K083248 · DXN
Andon Health Co, Ltd.
Cardiovascular · 87d
Cleared CT Jan 29, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902
K083317 · DXN
Andon Health Co, Ltd.
Cardiovascular · 80d
Cleared CT Jan 29, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904
K083318 · DXN
Andon Health Co, Ltd.
Cardiovascular · 80d
Cleared Jan 29, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941
K083319 · DXN
Andon Health Co, Ltd.
Cardiovascular · 80d
Cleared Jan 29, 2009
RELIEVA STRATUS MICROFLOW SPACER
K083574 · KAM
Acclarent, Inc.
General & Plastic Surgery · 57d
Cleared Jan 29, 2009
ASAHI SUOH PTCA GUIDE WIRE
K083904 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 31d
Cleared Jan 29, 2009
ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND...
K083915 · GEX
Advanced Technology Laser Co., Ltd.
General & Plastic Surgery · 30d
Cleared Jan 28, 2009
GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951
K081846 · DQO
Vascular Solutions, Inc.
Cardiovascular · 212d
Cleared Jan 28, 2009
CALTRIX RESORBABLE BONE VOID FILLER
K083279 · MQV
Ag Digital Technology Corp.
Orthopedic · 82d
Cleared Jan 28, 2009
PITT-EASY DENTAL IMPLANT SYSTEM
K083297 · DZE
Sybron Implant Solutions GmbH
Dental · 79d
Cleared Jan 28, 2009
NUVO VERDE LED LIGHTING SYSTEM
K083323 · FSY
Nuvo, Inc.
General & Plastic Surgery · 77d
Cleared Jan 28, 2009
SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022
K083528 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 61d
Cleared Jan 28, 2009
PACS SCAN
K083618 · LLZ
Pacsgear, Inc.
Radiology · 51d
Cleared Jan 28, 2009
PILOT SPINAL SYSTEM
K083865 · MNI
Life Spine
Orthopedic · 30d
Cleared Jan 28, 2009
THD SLIDE ONE
K090009 · JAF
Thd Spa
Radiology · 26d
Cleared Jan 28, 2009
COLOR LCD MONITOR, RADIFORCE RX320
K090045 · LLZ
Eizo Nanao Corporation
Radiology · 21d