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
71617–71640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 2003
MODIFICATION TO EASYS TRANSVERSE CONNECTION
K031290 · MNH
Scient'X USA, Inc.
Orthopedic · 20d
Cleared May 13, 2003
PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2
K031333 · IZI
Philips Medical Systems North...
Radiology · 15d
Cleared May 13, 2003
ADVANTAGE WORKSTATION PASTING 1.1
K031396 · LNH
GE Medical Systems
Radiology · 11d
Cleared May 12, 2003
COOLTOUCH ND: YAG LASER SYSTEM
K030453 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 90d
Cleared May 12, 2003
CELL-DYN 1800 SYSTEM
K030513 · GKZ
Abbott Laboratories
Hematology · 82d
Cleared May 12, 2003
AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM
K030775 · LKJ
Immuno Concepts, N.A. , Ltd.
Immunology · 62d
Cleared May 12, 2003
RANDOX AMMONIA
K030873 · JIF
Randox Laboratories, Ltd.
Chemistry · 53d
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