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
40465–40488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 2013
MAMMOMAT INSPIRATION PRIME
K123520 · MUE
Siemens Medical Solutions USA, Inc.
Radiology · 208d
Cleared Jun 11, 2013
SONENDO ENDOTHERAPY SYSTEM
K130025 · ELC
Sonendo, Inc.
Dental · 159d
Cleared Jun 11, 2013
PATHASSIST LED LIGHT FIBER
K130503 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 104d
Cleared Jun 11, 2013
DR LONG LENGTH IMAGING SOFTWARE
K130567 · MQB
Carestream Health, Inc.
Radiology · 99d
Cleared Jun 11, 2013
DISPOSABLE CIRCULAR STAPLER
K131303 · GDW
Changzhou City Zhiye Medical Devices...
General & Plastic Surgery · 35d
Cleared Jun 11, 2013
NON-PYROGENIC ULTRASOUND TRANSDUCER COVER
K131528 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 14d
Cleared Jun 10, 2013
DISPOSABLE 330PSI EXTENSION LINES
K120892 · DXT
Coeur, Inc.
Cardiovascular · 444d
Cleared Jun 10, 2013
STARBAND
K124023 · OAN
Orthomerica Products, Inc.
Neurology · 164d
Cleared Jun 10, 2013
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
K130907 · KTT
Stryker Trauma AG
Orthopedic · 70d
Cleared Jun 10, 2013
ACUMED TOTALW RIST FUSION PLATING SYSTEM
K131380 · HRS
Acumed, LLC
Orthopedic · 27d
Cleared Jun 07, 2013
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL...
K120945 · CKA
Hitachi Chemical Diagnostics, Inc.
Chemistry · 435d
Cleared Jun 07, 2013
XGEO GU60
K123105 · KPR
Samsung Electronics Co., Ltd.
Radiology · 248d
Cleared Jun 07, 2013
IMR SOFTWARE APPLICATION
K123576 · JAK
Philips Healthcare (Cleveland)
Radiology · 199d
Cleared Jun 07, 2013
DIAZYME MYOGLOBIN
K123785 · DDR
Diazyme Laboratories
Chemistry · 179d
Cleared Jun 07, 2013
4WEB OSTEOTOMY BONE WEDGE
K130185 · HRS
4-Web, Inc.
Orthopedic · 133d
Cleared Jun 07, 2013
BEARING NSPVA EMBOLIZATION PARTICLES
K130259 · NAJ
Merit Medical Systems, Inc.
Obstetrics & Gynecology · 126d
Cleared Jun 07, 2013
FASTBRACES CERAMIC BRACKETS
K130446 · NJM
Orthodontic Design and Production, Inc.
Dental · 106d
Cleared Jun 07, 2013
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
K130464 · MQB
Carestream Health, Inc.
Radiology · 105d
Cleared Jun 07, 2013
TELERADPRO EDGE
K130636 · LMA
Vidar Systems Corp.
Radiology · 88d
Cleared Jun 07, 2013
DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK
K130726 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 81d
Cleared Jun 07, 2013
PRELUDE SHEATH INTRODUCER
K130791 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 77d
Cleared Jun 07, 2013
ISR'OBOT MONA LISA
K130944 · IYO
Biobot Surgical Pte., Ltd.
Radiology · 64d
Cleared Jun 07, 2013
HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)
K131051 · JGQ
Hitachi Chemical Diagnostics, Inc.
Chemistry · 53d
Cleared Jun 07, 2013
LIMACORPORATE SMR CTA HUMERAL HEADS
K131112 · KWS
Lima Corporate S.P.A.
Orthopedic · 46d