FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
72073–72096 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 21, 2003
CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
K030768 · JJT
Cliniqa Corporation
Chemistry · 10d
Cleared Mar 21, 2003
STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH...
K030853 · FRG
Case Medical, Inc.
General Hospital · 3d
Cleared Mar 20, 2003
ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1...
K022947 · DTQ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 196d
Cleared Mar 20, 2003
FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS
K023162 · FIE
Fresenius Medical Care
Gastroenterology & Urology · 178d
Cleared Mar 20, 2003
VISTA BASIC WITH FM SYSTEM
K023189 · FRN
B.Braun Medical, Inc.
General Hospital · 177d
Cleared Mar 20, 2003
STRYKER BIOZIP SUTURE ANCHOR
K023192 · HWC
Stryker Endoscopy
Orthopedic · 176d
Cleared Mar 20, 2003
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
K023487 · GEH
OraSure Technologies, Inc.
General & Plastic Surgery · 154d
Cleared Mar 20, 2003
GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER
K023692 · LWJ
Howmedica Osteonics Corp.
Orthopedic · 136d
Cleared Mar 20, 2003
CRYOPROBE
K024009 · GEH
H&O Equipments, Nv/Sa
General & Plastic Surgery · 106d