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
72577–72600 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 2003
PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS
K022212 · JOH
Mentor Medical Limited
Anesthesiology · 256d
Cleared Mar 21, 2003
MODIFICATION TO NASAL-AIRE
K022465 · BZD
Innomed Technologies
Anesthesiology · 238d
Cleared Mar 21, 2003
POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK)
K022873 · KGO
International Biomedical, Inc.
General Hospital · 204d
Cleared Mar 21, 2003
BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED...
K023078 · DXN
Vsm Medtech , Ltd.
Cardiovascular · 186d
Cleared Mar 21, 2003
CHROMOPHARE X 65
K024132 · FSY
Berchtold Holding GmbH
General & Plastic Surgery · 95d
Cleared Mar 21, 2003
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
K024260 · GEX
Candela Corp.
General & Plastic Surgery · 88d
Cleared Mar 21, 2003
ACRYLIC
K024282 · EBG
Inovativ, LLC
Dental · 88d
Cleared Mar 21, 2003
FIXOBRIDGE 3-CEMENT
K024287 · EMA
Advanced Healthcare , Ltd.
Dental · 88d
Cleared Mar 21, 2003
JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3
K024329 · INI
Ji-Ee Industry Co., Ltd.
Physical Medicine · 85d
Cleared Mar 21, 2003
CROSSEAL APPLICATION DEVICE
K030032 · FMI
Omrix Biopharmaceuticals, Inc.
General Hospital · 77d
Cleared Mar 21, 2003
100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
K030107 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 67d
Cleared Mar 21, 2003
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K030114 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 67d
Cleared Mar 21, 2003
AGC CEM
K030168 · EMA
Wieland Dental + Technik GmbH & Co. KG
Dental · 63d
Cleared Mar 21, 2003
ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH...
K030331 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 49d
Cleared Mar 21, 2003
LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING...
K030333 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 49d
Cleared Mar 21, 2003
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA
K030397 · MSV
Hycor Biomedical , Ltd.
Immunology · 43d
Cleared Mar 21, 2003
POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE
K030560 · LYY
Pt.Shamrock Manufacturing Corp.
General Hospital · 28d
Cleared Mar 21, 2003
MODIFICATION TO SOLAR 9500 INFORMATION MONITOR
K030575 · MHX
Ge Medical Systems Information...
Cardiovascular · 25d
Cleared Mar 21, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NALIDIXIC ACID - 2-32 UG/ML
K030579 · LON
Becton, Dickinson & CO
Microbiology · 25d
Cleared Mar 21, 2003
CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)
K030590 · DHB
Hitachi Chemical Diagnostics, Inc.
Immunology · 24d
Cleared Mar 21, 2003
POD PAC-20M
K030610 · IYO
Portable Ophthalmic Devices, Inc.
Radiology · 23d
Cleared Mar 21, 2003
INFINITY EXPLORER
K030615 · MSX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 23d
Cleared Mar 21, 2003
SIEMENS INFINITY GATEWAY SUITE, MODEL VF2
K030657 · MHX
Siemens Medical Solutions
Cardiovascular · 18d
Cleared Mar 21, 2003
M2376A DEVICELINK SYSTEM
K030731 · MWI
Philips Medical Systems, Inc.
Cardiovascular · 11d