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
61513–61536 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 2006
DIMENSION VISTA RF FLEX REAGENT CARTRIDGE
K062035 · JIX
Dade Behring, Inc.
Immunology · 77d
Cleared Oct 04, 2006
V.A.C. THERAPY SYSTEM
K062227 · OMP
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 63d
Cleared Oct 04, 2006
KARMA MANUAL WHEELCHAIR, MODEL BUDGET 800
K062311 · IOR
Karma Medical Products Co., Ltd.
Physical Medicine · 57d
Cleared Oct 04, 2006
XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND...
K062549 · ETN
Excel Tech. , Ltd.
Ear, Nose, Throat · 35d
Cleared Oct 04, 2006
MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM
K062617 · HWC
Inion , Ltd.
Orthopedic · 29d
Cleared Oct 04, 2006
SMARTSUCTION SOLO DEVICE
K062801 · BTA
Haemonetics Corp.
General & Plastic Surgery · 15d
Cleared Oct 03, 2006
MEDICAL COMPRESSOR, MODELS DK50 D AND DM
K060781 · BTI
Ekom S.R.O.
Anesthesiology · 195d
Cleared Oct 03, 2006
SANDMAN POCKET
K061996 · MNR
Eb Neuro S.P.A.
Anesthesiology · 81d
Cleared Oct 03, 2006
SBI TRIHEDRON MTP HEMI GT
K062040 · KWD
Small Bone Innovations, Inc.
Orthopedic · 76d
Cleared Oct 03, 2006
SOLAR REUNION FRACTURE STEM
K062113 · KWS
Howmedica Osteonics Corp.
Orthopedic · 71d
Cleared Oct 03, 2006
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
K062751 · JJT
Quantimetrix Corp.
Chemistry · 19d
Cleared Oct 02, 2006
SPERMSLOW
K061145 · MQL
Medicult A/S
Obstetrics & Gynecology · 160d
Cleared Oct 02, 2006
COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID
K061746 · KGN
Innocoll Pharmaceuticals
General & Plastic Surgery · 103d
Cleared Oct 02, 2006
ABX PENTRA AMYLASE CP
K062180 · JFJ
Horiba Abx
Chemistry · 63d
Cleared Oct 02, 2006
OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR
K062244 · OCW
Arthrocare Corp.
Gastroenterology & Urology · 60d
Cleared Oct 02, 2006
SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100
K062320 · FTM
Cook Biotech, Inc.
General & Plastic Surgery · 54d
Cleared Oct 02, 2006
GRANDIO SEAL
K062344 · EBC
Voco GmbH
Dental · 52d
Cleared Oct 02, 2006
OPTIME, SINUSORB PGA
K062366 · GAM
Peters Surgical
General & Plastic Surgery · 49d
Cleared Sep 29, 2006
PULSE OXIMETER ADAPTER CABLES
K052544 · DQA
American I.V. Products, Inc.
Anesthesiology · 379d
Cleared Sep 29, 2006
INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200
K052870 · NZP
Kimberly-Clark Corp.
General Hospital · 353d
Cleared Sep 29, 2006
CLIRPATH TURBO PERIPHERAL CATHETERS
K060012 · PDU
Spectranetics Corp.
Cardiovascular · 269d
Cleared Sep 29, 2006
ACUMED LASER, MODEL 1000
K060153 · ILY
Laser Thera, LLC
Physical Medicine · 252d
Cleared Sep 29, 2006
ABX PENTRA 400 : CRP
K061138 · DCK
Horiba Abx
Chemistry · 158d
Cleared Sep 29, 2006
MULTICATH EXPERT
K061250 · FOZ
Vygon Corp.
General Hospital · 148d