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
87769–87792 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1998
MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K983718 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Dec 11, 1998
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE
K983729 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 50d
Cleared Dec 11, 1998
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE
K983730 · LZA
Omnigrace , Ltd.
General Hospital · 50d
Cleared Dec 11, 1998
INJECTION NEEDLE PROBE/DEVICE-TUNIS
K983765 · FBK
Ximed/Prosure/Injectx
Gastroenterology & Urology · 46d
Cleared Dec 11, 1998
SEARE BIOMEDICAL SILICONE TISSUE EXPANDER
K983792 · LCJ
Seare Biomedical Corp.
General & Plastic Surgery · 45d
Cleared Dec 11, 1998
PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE
K983821 · LLZ
Philips Medical Systems North...
Radiology · 43d
Cleared Dec 11, 1998
FV-RF
K984111 · KPR
Philips Medical Systems (Cleveland),...
Radiology · 24d
Cleared Dec 11, 1998
MODIFICATION TO PROWESS PRO-SIM
K984196 · MUJ
Ssgi Prowess Systems
Radiology · 18d
Cleared Dec 11, 1998
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000
K984272 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 11d
Cleared Dec 11, 1998
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II
K984278 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 11d
Cleared Dec 11, 1998
AVL OPTI CRITICAL CARE ANALYZER
K984299 · JFP
Avl Scientific Corp.
Chemistry · 10d
Cleared Dec 10, 1998
INTERSOURCE
K973328 · KXK
International Brachytherapy S.A.
Radiology · 462d
Cleared Dec 10, 1998
MEDTRONIC ANGIOGRAPHIC CATHETER
K980973 · DQO
Medtronics Interventional Vascular
Cardiovascular · 269d
Cleared Dec 10, 1998
LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC...
K981922 · QPB
Microaire Surgical Instruments, Inc.
General & Plastic Surgery · 192d
Cleared Dec 10, 1998
CLEARVIEW IM
K981946 · KTN
Unipath , Ltd.
Immunology · 190d
Cleared Dec 10, 1998
AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM
K982076 · CGA
Amira Medical, Inc.
Chemistry · 181d
Cleared Dec 10, 1998
ALOE THERAPY ORAL RINSE
K983182 · OLR
Carrington Laboratories, Inc.
General & Plastic Surgery · 90d
Cleared Dec 10, 1998
GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON,...
K983183 · EFB
Bien Air USA, Inc.
Dental · 90d
Cleared Dec 10, 1998
MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE
K983187 · KNW
Medsol Corp.
Gastroenterology & Urology · 90d
Cleared Dec 10, 1998
ALGISITE M
K983210 · KMF
Smith & Nephew, Inc.
General & Plastic Surgery · 87d
Cleared Dec 10, 1998
MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T
K983412 · LJS
Medical Components, Inc.
General Hospital · 73d
Cleared Dec 10, 1998
GORE REVOX THYROPLASTY IMPLANT
K983525 · MIX
W.L. Gore & Associates, Inc.
Ear, Nose, Throat · 63d
Cleared Dec 10, 1998
ALUMINA-ZINC OXIDE POWDERS F AND R
K983752 · EMA
Harry J. Bosworth Co.
Dental · 48d
Cleared Dec 10, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN...
K983801 · LSE
Zeus Scientific, Inc.
Microbiology · 43d