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

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175,820 results
42649–42672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 2012
MOBILE CAREGUIDE 2100 OXIMETER
K122645 · MUD
Reflectance Medical, Inc.
Cardiovascular · 97d
Cleared Dec 05, 2012
ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM
K122745 · MBH
Zimmer, Inc.
Orthopedic · 89d
Cleared Dec 05, 2012
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)
K122759 · LDJ
Omega Laboratories, Inc.
Toxicology · 86d
Cleared Dec 05, 2012
CALYPSO SYSTEM
K123137 · IYE
Varian Medical Systems
Radiology · 61d
Cleared Dec 05, 2012
VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
K123197 · OZN
Nanosphere, Inc.
Microbiology · 55d
Cleared Dec 05, 2012
LESSRAY
K123226 · OWB
Saferay Spine, LLC
Radiology · 51d
Cleared Dec 05, 2012
ACUSON
K123622 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 12d
Cleared Dec 03, 2012
ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT
K120995 · LLZ
Erad, Inc.
Radiology · 245d
Cleared Dec 03, 2012
RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611,...
K122660 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 94d
Cleared Dec 03, 2012
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMS
K122692 · PHX
Zimmer, Inc.
Orthopedic · 90d
Cleared Dec 03, 2012
GALLEON PEDICLE SCREW SYSTEM
K122814 · MNH
Everest Spine, LLC
Orthopedic · 81d
Cleared Dec 03, 2012
LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS
K122829 · HQC
Lensar, Inc.
Ophthalmic · 77d
Cleared Dec 03, 2012
FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM
K122901 · NKB
Orthofix
Orthopedic · 73d
Cleared Dec 03, 2012
BWF-5 MEDICAL LASER SERIES
K123031 · GEX
Litecure, LLC
General & Plastic Surgery · 66d
Cleared Dec 03, 2012
POLARIS SPINAL SYSTEM - BALLISTA II RODS
K123451 · NKB
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 24d
Cleared Dec 03, 2012
INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS
K123463 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 24d
Cleared Nov 30, 2012
GENSTRIP TEST STRIP MODEL 100-201
K103542 · NBW
Shasta Technologies, LLC
Chemistry · 729d
Cleared Nov 30, 2012
HARD SHELL VENTED NASAL MASK
K121321 · BZD
Sleepnet Corporation
Anesthesiology · 212d
Cleared Nov 30, 2012
CURALINE POLYURETHANE FOAM AWC DRESSING
K121361 · FRO
Curaline, Inc.
General & Plastic Surgery · 207d
Cleared Nov 30, 2012
HYLATOPICPLUS LOTION
K121559 · FRO
Precision Dermatology Incorporated
General & Plastic Surgery · 185d
Cleared Nov 30, 2012
NAVIOPFS
K121936 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 151d
Cleared Nov 30, 2012
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA...
K121994 · CDD
Siemens Healthcare Diagnostics, Inc.
Chemistry · 147d
Cleared Nov 30, 2012
SMARTTOOLS KNEE SYSTEM
K122326 · OLO
Zimmer
Orthopedic · 121d
Cleared Nov 30, 2012
UCP HOME DRUG SCREENING TEST CUPS
K122419 · DKZ
Ucp Biosciences, Inc.
Toxicology · 113d