FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

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

Filters: Cleared only ×
175,820 results
136489–136512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 1988
N PROTEIN STANDARD PLASMA (HUMAN)
K880356 · CFN
Behring Diagnostics, Inc.
Immunology · 72d
Cleared Apr 07, 1988
ORTHOLUX VISIBLE LIGHT CURING UNIT
K880392 · EBZ
Unitek Corp.
Dental · 69d
Cleared Apr 07, 1988
VITALLIUM EQUIPOISE ALLOY
K880875 · EJH
Austenal Dental, Inc.
Dental · 37d
Cleared Apr 07, 1988
GENERAL PURPOSE KIT
K881083 · LRO
Med-Dex Intl.
General & Plastic Surgery · 24d
Cleared Apr 07, 1988
THERMAFIL ENDODONTIC OBTURATOR
K881139 · EKM
Tulsa Dental Products, Ltd.
Dental · 21d
Cleared Apr 07, 1988
RECTANGULAR NITINOL ARCH WIRE
K881163 · EJF
Flexmedics
Dental · 20d
Cleared Apr 07, 1988
MONO-PHILE
K881247 · KTN
Bio Diagnostic Systems, Inc.
Immunology · 15d
Cleared Apr 07, 1988
ALLEN LATERAL ARMBOARD
K881292 · BTX
Edgewater Medical Systems, Inc.
General & Plastic Surgery · 10d
Cleared Apr 06, 1988
CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION)
K872356 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 293d
Cleared Apr 06, 1988
SAFECON CONDOMS
K874399 · HIS
Quality Synthetics Intl, Inc.
Obstetrics & Gynecology · 161d
Cleared Apr 06, 1988
QUIDEL ALLERGY SCREEN
K874717 · DHB
Quidel Corp.
Immunology · 141d
Cleared Apr 06, 1988
EFFNER FE-EX* OROGASTRIC
K874755 · KNT
Effner and Spreine Co.
Gastroenterology & Urology · 140d
Cleared Apr 06, 1988
J-CATH(TM)
K875171 · KNT
Hdc Corp.
Gastroenterology & Urology · 111d
Cleared Apr 06, 1988
MEDELA BREAST-PUMP LACTINA
K875300 · HGX
Medela, Inc.
Obstetrics & Gynecology · 99d
Cleared Apr 06, 1988
SM ANTIBODY TEST KIT
K880254 · LKP
Lipogen, Inc.
Immunology · 77d
Cleared Apr 06, 1988
POLE, INTRAVENOUS
K880537 · FOX
Ferguson Medical
General Hospital · 57d
Cleared Apr 06, 1988
TECA/MEDELEC MISTRAL
K880593 · GWE
Teca, Inc.
Neurology · 55d
Cleared Apr 06, 1988
ENDOSCOPIC ELASTIC BAND LIGATOR
K880648 · FHN
Superior Healthcare Group, Inc.
Gastroenterology & Urology · 49d
Cleared Apr 06, 1988
ULTIMA XS (TENS)
K880751 · GZJ
American Imex
Neurology · 42d
Cleared Apr 06, 1988
KOI(TM) INSTRUMENT TRAYS
K881095 · LRP
CooperVision, Inc.
General & Plastic Surgery · 22d
Cleared Apr 06, 1988
K ORTHOPEDIC TABLE
K881101 · JEB
Instrumentation Specialties, Inc.
General & Plastic Surgery · 22d
Cleared Apr 06, 1988
QM300 ALBUMIN ANTIBODY PACK
K881126 · DCF
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 21d
Cleared Apr 06, 1988
MICROSCRAPE
K881151 · LXK
Ortho Pharmaceutical Corp.
General & Plastic Surgery · 20d
Cleared Apr 06, 1988
STERNUM SPREADER AND MITRAL VALVE RETRACTOR
K881157 · GAD
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 19d