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
72745–72768 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 2003
MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER
K031259 · FLE
Getinge USA, Inc.
General Hospital · 21d
Cleared May 12, 2003
ELECSYS LH CALSET II
K031299 · JIT
Roche Diagnostics Corp.
Chemistry · 18d
Cleared May 12, 2003
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP...
K031330 · DQA
Masimo Corp.
Anesthesiology · 14d
Cleared May 09, 2003
HERO
K021230 · DPS
Medical Decision Networks
Cardiovascular · 386d
Cleared May 09, 2003
HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM
K021813 · FQH
Hydrocision, Inc.
General Hospital · 340d
Cleared May 09, 2003
DIATEK CANNON-CATHETER, MODEL CC5500
K022662 · MSD
Arrow Intl., Inc.
Gastroenterology & Urology · 273d
Cleared May 09, 2003
STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS
K022978 · FRG
Case Medical, Inc.
General Hospital · 245d
Cleared May 09, 2003
PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2
K023338 · DXN
Fms, Finapres Medical Systems BV
Cardiovascular · 214d
Cleared May 09, 2003
IGI-SYSTEM
K023424 · HAW
Denx Advanced Dental Systems
Neurology · 210d
Cleared May 09, 2003
OPAQUE HERRICK LACRIMAL PLUG
K030300 · LZU
Lacrimedics, Inc.
Ophthalmic · 100d
Cleared May 09, 2003
DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE),...
K030417 · LDD
Philips Medical Systems
Cardiovascular · 88d
Cleared May 09, 2003
POWERLITE 600 EP SYSTEM
K030423 · GEX
Preswede AB
General & Plastic Surgery · 88d
Cleared May 09, 2003
MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST
K030443 · KNW
Nastech Pharmaceutical Company, Inc.
Gastroenterology & Urology · 87d
Cleared May 09, 2003
OSTEOMED 2.0 LOCKING PLATES AND SCREWS
K030448 · JEY
Osteomed LP
Dental · 87d
Cleared May 09, 2003
LAPAROSHIELD CONDITIONED INSUFFLATION SET
K030469 · HIF
Pall Medical
Obstetrics & Gynecology · 86d
Cleared May 09, 2003
DEPILASE YAG LASE PLUS LASER SYSTEM
K030506 · GEX
Depilase Group , Ltd.
General & Plastic Surgery · 79d
Cleared May 09, 2003
MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL-100A
K030561 · DXN
Mytech Technology Co., Ltd.
Cardiovascular · 77d
Cleared May 09, 2003
SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR
K030680 · JOJ
Spsmedical Supply Corp.
General Hospital · 65d
Cleared May 09, 2003
ETCHANT 40%
K030743 · KLE
Confi-Dental Products Co.
Dental · 60d
Cleared May 09, 2003
MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL
K030776 · ELW
Discus Dental, Inc.
Dental · 59d
Cleared May 09, 2003
STACKED ABR FOR NAVIGATOR PRO
K030907 · GWJ
Bio-Logic Systems Corp.
Neurology · 46d
Cleared May 09, 2003
C3 PATIENT MONITOR
K030931 · MHX
Analogic Corp.
Cardiovascular · 45d
Cleared May 09, 2003
AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)
K031008 · HBA
Aesculap
Neurology · 39d
Cleared May 09, 2003
NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005
K031156 · HAW
Orthosoft, Inc.
Neurology · 28d