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
51889–51912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 2009
PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S,...
K092377 · NHA
Zimmer Dental, Inc.
Dental · 90d
Cleared Nov 03, 2009
R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS
K092386 · MBL
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Nov 03, 2009
INTRA LUX HEAD 3 LDSY
K092446 · EFA
Kaltenbach & Voigt GmbH & Co.
Dental · 85d
Cleared Nov 03, 2009
CAPRI APPLICATOR
K092822 · JAQ
Vivaray, Inc.
Radiology · 50d
Cleared Nov 02, 2009
ETEST VORICONAZOLE 0.002-32 UG/ML
K082534 · NGZ
Ab Biomerieux
Microbiology · 426d
Cleared Nov 02, 2009
KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX
K091192 · NPL
Kensey Nash Corp.
Dental · 193d
Cleared Nov 02, 2009
CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY...
K091531 · ODP
Choice Spine, Llp
Orthopedic · 160d
Cleared Nov 02, 2009
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE
K091607 · MQV
Etex Corp.
Orthopedic · 152d
Cleared Nov 02, 2009
POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY...
K091643 · LZC
Gx Corporation Sdn Bhd
General Hospital · 151d
Cleared Nov 02, 2009
ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM...
K091653 · ORI
ARK Diagnostics, Inc.
Toxicology · 146d
Cleared Nov 02, 2009
SEC VBR
K091743 · MQP
Innvotec Surgical, Inc.
Orthopedic · 139d
Cleared Nov 02, 2009
KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400,...
K092167 · FRG
Kimberly-Clark Corp.
General Hospital · 104d
Cleared Nov 02, 2009
DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM
K092317 · HRS
Deroyal Industries, Inc.
Orthopedic · 90d
Cleared Nov 02, 2009
ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A
K092359 · FCG
Cook Ireland, Ltd.
Gastroenterology & Urology · 90d
Cleared Nov 02, 2009
SLEEPWEAVER NASAL CPAP MASK
K092362 · BZD
Circadiance, LLC
Anesthesiology · 90d
Cleared Nov 02, 2009
SPECTRANETICS VISISHEATH DILATOR SHEATH
K092378 · DRE
Spectranetics Corp.
Cardiovascular · 89d
Cleared Nov 02, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K092790 · LYZ
Zibo Boxiang Plastic & Rubber Co., Ltd.
General Hospital · 53d
Cleared Oct 30, 2009
SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX...
K083133 · FRO
Andover Healthcare, Inc.
General & Plastic Surgery · 372d
Cleared Oct 30, 2009
BIPAP AUTOSV ADVANCED
K090539 · MNS
Respironics Inc., Sleep & Home...
Anesthesiology · 245d
Cleared Oct 30, 2009
ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL...
K090887 · ODP
SpineCraft
Orthopedic · 213d
Cleared Oct 30, 2009
ECO2 LASER SYSTEM
K091115 · GEX
Lutronic Corporation
General & Plastic Surgery · 196d
Cleared Oct 30, 2009
SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET
K091441 · FRN
Synergetics, Inc.
General Hospital · 168d
Cleared Oct 30, 2009
BUILD-IT LIGHT CURE
K091512 · EBF
Pentron Clinical Technologies
Dental · 162d
Cleared Oct 30, 2009
SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2
K091736 · MMK
Daniels Corporation Pty, Inc.
General Hospital · 141d