FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
72121–72144 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 2003
OLYMPIC CFM 6000
K031149 · OMA
Olympic Medical Corp.
Neurology · 34d
Cleared May 14, 2003
MATRIX STRETCH RESISTANT DETACHABLE COIL
K031168 · HCG
Boston Scientific, Target
Neurology · 30d
Cleared May 14, 2003
JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS...
K031277 · DQX
Jomed, Inc.
Cardiovascular · 22d
Cleared May 14, 2003
IBC FLOPUMP WITH GBS COATING
K031300 · KFM
Gish Biomedical, Inc.
Cardiovascular · 20d
Cleared May 13, 2003
DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000
K022834 · MHX
Ge Medical Systems Information...
Cardiovascular · 260d
Cleared May 13, 2003
INBODY AP1 BODY COMPOSITION ANALYZER
K023478 · MNW
Biospace Co.,Ltd
Gastroenterology & Urology · 209d
Cleared May 13, 2003
SYREX PRE-FILLED SYRINGE
K023740 · NZW
Excelsior Medical Corp.
General Hospital · 187d
Cleared May 13, 2003
MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
K030209 · MPB
The Kendall Company
Gastroenterology & Urology · 112d
Cleared May 13, 2003
EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE
K031037 · DWF
Medtronic Perfusion Systems
Cardiovascular · 42d
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