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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
73465–73488 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 2002
GOLD CORE 35
K023501 · EJT
Pentron Laboratory Technologies
Dental · 61d
Cleared Dec 18, 2002
JEWEL CAST PLUS
K023502 · EJH
Pentron Laboratory Technologies
Dental · 61d
Cleared Dec 18, 2002
BURETTE-IN LINE (150 ML)
K023595 · FPA
Tuta Healthcare Pty Limited
General Hospital · 51d
Cleared Dec 18, 2002
POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE
K023702 · LZA
Ningbo Tianshun Rubber Products Co.,...
General Hospital · 47d
Cleared Dec 18, 2002
ST AIA-PACK CEA ENZYME IMMUNOASSAY
K023893 · DHX
Tosoh Medics, Inc.
Immunology · 26d
Cleared Dec 18, 2002
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA...
K023907 · KNQ
Cordis Corp.
Gastroenterology & Urology · 23d
Cleared Dec 18, 2002
ALOKA SSD-3500 ULTRASOUND SYSTEM
K023996 · IYN
Aloka Co., Ltd.
Radiology · 15d
Cleared Dec 18, 2002
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR
K024025 · LZA
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 12d
Cleared Dec 18, 2002
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K024026 · LYZ
Shanghai PM Plastics Enterise Co., Ltd.
General Hospital · 12d
Cleared Dec 18, 2002
OCCLUFAST ROCK
K024034 · ELW
Zhermack S.P.A.
Dental · 12d
Cleared Dec 18, 2002
ZETAPLUS SOFT
K024041 · ELW
Zhermack S.P.A.
Dental · 12d
Cleared Dec 18, 2002
DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K024102 · LYY
Allegiance Healthcare Corp.
General Hospital · 6d
Cleared Dec 18, 2002
SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM
K024108 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 5d
Cleared Dec 17, 2002
ISOROD PD-103 IMPLANT, MODEL ATI-PD-103
K020683 · KXK
Ati Medical, Inc.
Radiology · 288d
Cleared Dec 17, 2002
VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER
K022028 · KPJ
Vascular One, Inc.
General & Plastic Surgery · 179d
Cleared Dec 17, 2002
PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022177 · LTJ
Bayer Diagnostics Corp.
Immunology · 167d
Cleared Dec 17, 2002
UNIVERSAL CMF SYSTEM
K022185 · JEY
Stryker Instruments
Dental · 167d
Cleared Dec 17, 2002
COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA...
K022288 · LTJ
Bayer Corp.
Immunology · 155d
Cleared Dec 17, 2002
ST AIA-PACK TESTOSTERONE ASSAY
K023091 · CDZ
Tosoh Medics, Inc.
Chemistry · 91d
Cleared Dec 17, 2002
IRIDIS OPHTHALMIC PHOTOCOAGULATOR
K023094 · HQF
Quantel Medical
Ophthalmic · 90d
Cleared Dec 17, 2002
PROSOLV CARDIVASCULAR VIEWER
K023112 · DQK
Problem Solving Concepts, Inc.
Cardiovascular · 89d
Cleared Dec 17, 2002
JOSTRA MECC SYSTEM
K023132 · KFM
Jostra AG
Cardiovascular · 88d
Cleared Dec 17, 2002
IMMULITE 2000 ALLERGEN-SPECIFIC IGE
K023152 · DHB
Diagnostic Products Corp.
Immunology · 85d
Cleared Dec 17, 2002
ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800
K023185 · KRH
Sulzer Carbomedics, Inc.
Cardiovascular · 84d