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
64177–64200 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 2005
POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN...
K050526 · LYY
Spi Gloves Sdn. Bhd.
General Hospital · 279d
Cleared Dec 06, 2005
VERIFY FLASH INTEGRATOR
K051101 · JOJ
Albert Browne , Ltd.
General Hospital · 221d
Cleared Dec 06, 2005
INTERBODY INNOVATIONS CEMENT RESTRICTOR
K051371 · JDK
Interbody Innovations, Llp
Orthopedic · 194d
Cleared Dec 06, 2005
INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC
K051638 · GTY
Unipath , Ltd.
Microbiology · 169d
Cleared Dec 06, 2005
GELITA-SPON
K051911 · KHJ
Curamedical, BV
Ear, Nose, Throat · 145d
Cleared Dec 06, 2005
BIOFINITY (COMFILCON A) SOFT CONTACT LENS
K052560 · LPL
CooperVision, Inc.
Ophthalmic · 81d
Cleared Dec 06, 2005
INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024,...
K052738 · KRA
Veinrx, Inc.
Cardiovascular · 67d
Cleared Dec 06, 2005
POROUS TITANIUM ACETABULAR AUGMENTS
K052888 · KWA
Biomet Manufacturing Corp
Orthopedic · 54d
Cleared Dec 06, 2005
OPTIMIZED BARB DESIGN
K052962 · GAW
Surgical Specialties Corp
General & Plastic Surgery · 46d
Cleared Dec 06, 2005
XIA SPINAL SYSTEM
K053115 · MNI
Stryker Spine
Orthopedic · 29d
Cleared Dec 06, 2005
ARTHROCARE 8000S COBLATOR SURGERY SYSTEM
K053297 · GEI
Arthrocare Corp.
General & Plastic Surgery · 11d
Cleared Dec 05, 2005
VIAGRAF DBM PASTE
K043209 · MBP
Osteotech, Inc.
Orthopedic · 381d
Cleared Dec 05, 2005
MANI NEEDLE & SUTURE PACK
K050150 · GAT
Mani, Inc.
General & Plastic Surgery · 315d
Cleared Dec 05, 2005
ORTHOBLAST II PUTTY AND PASTE
K050642 · MBP
Isotis Orthobiologics, Inc.
Orthopedic · 269d
Cleared Dec 05, 2005
SILVERSEAL SILVERAID WITH X-STATIC
K050726 · FRO
Noble Fiber Technologies, Inc.
General & Plastic Surgery · 262d
Cleared Dec 05, 2005
MEDI BUTLER
K051324 · DWL
Medi USA, LP
General Hospital · 199d
Cleared Dec 05, 2005
ELECSYS PROBNP IMMUNOASSAY
K051382 · NBC
Roche Diagnostics Corp.
Chemistry · 192d
Cleared Dec 05, 2005
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.
K051484 · LFY
Zeus Scientific, Inc.
Microbiology · 182d
Cleared Dec 05, 2005
LINEAGE A-CLASS POLY LINER
K052026 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 131d
Cleared Dec 05, 2005
DUOPROSS NEEDLE
K052445 · FMI
Duopross Meditech Corporation
General Hospital · 89d
Cleared Dec 05, 2005
ANSPACH KNOTLESS ANCHOR
K052572 · MBI
The Anspach Effort, Inc.
Orthopedic · 77d
Cleared Dec 05, 2005
BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
K052625 · NYN
Bionicare Medical Technologies, Inc.
Neurology · 73d
Cleared Dec 05, 2005
SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
K052644 · DYB
St Jude Medical
Cardiovascular · 70d
Cleared Dec 05, 2005
SYNTHES (USA) STERNAL FIXATION SYSTEM
K052683 · HRS
Synthes (Usa)
Orthopedic · 68d