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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
73201–73224 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 20, 2003
OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM
K024012 · JAA
Ge Oec Medical Systems
Radiology · 106d
Cleared Mar 20, 2003
ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475
K024291 · HRX
Arthrex, Inc.
Orthopedic · 86d
Cleared Mar 20, 2003
ENHANCE SPERM FREEZE
K030117 · MQL
Conception Technology, Inc.
Obstetrics & Gynecology · 66d
Cleared Mar 20, 2003
MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6,...
K030149 · FPA
Avail Medical Products, Inc.
General Hospital · 64d
Cleared Mar 20, 2003
POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE
K030200 · LYZ
Kaohsiung Brothers Products Corp.
General Hospital · 58d
Cleared Mar 20, 2003
GENICON CLIP APPLIER
K030269 · FZP
Genicon, LC
General & Plastic Surgery · 52d
Cleared Mar 20, 2003
KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
K030368 · HWC
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 44d