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
86737–86760 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1999
APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM
K984138 · LSR
Zeus Scientific, Inc.
Microbiology · 125d
Cleared Mar 23, 1999
RANDOX ALBUMIN
K984494 · CIX
Randox Laboratories, Ltd.
Chemistry · 96d
Cleared Mar 23, 1999
SYNERGY D2 SPINAL IMPLANTS
K984578 · MNI
Interpore Cross Intl.
Orthopedic · 90d
Cleared Mar 23, 1999
EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES
K990013 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 78d
Cleared Mar 23, 1999
LACTOSORB BONE PIN
K990291 · HTY
Biomet, Inc.
Orthopedic · 53d
Cleared Mar 23, 1999
DEPUY ACE SPIDER PLATE
K990392 · HRS
Depuy Ace Medical Co.
Orthopedic · 42d
Cleared Mar 23, 1999
THE.R.MO.FREE
K990448 · EBI
Dentamax, Inc.
Dental · 39d
Cleared Mar 23, 1999
HERMES OPERATING ROOM CONTROL CENTER
K990691 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 20d
Cleared Mar 23, 1999
SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM
K990746 · LYY
Southland Products Co., Ltd.
General Hospital · 15d
Cleared Mar 23, 1999
SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES
K990751 · LYY
Southland Products Co., Ltd.
General Hospital · 15d
Cleared Mar 23, 1999
DIRECTFLOW ARTERIAL CANNULA
K990772 · DWF
Heartport, Inc.
Cardiovascular · 14d
Cleared Mar 22, 1999
ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW
K981858 · DZE
Atlantis Components, Inc.
Dental · 299d
Cleared Mar 22, 1999
NEUROTUBE
K983007 · JXI
Neuroregen, LLC
Neurology · 206d
Cleared Mar 22, 1999
ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM
K983879 · IYO
Aloka Co., Ltd.
Radiology · 140d
Cleared Mar 22, 1999
AIR TECHNIQUES' DENTO-VAC
K984584 · EIA
Air Techniques, Inc.
Dental · 88d
Cleared Mar 22, 1999
DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE
K990090 · GAR
Aesculap, Inc.
General & Plastic Surgery · 70d
Cleared Mar 22, 1999
ISOBAR SPINAL SYSTEM
K990118 · MNH
Scien'Tx USA, Inc.
Orthopedic · 68d
Cleared Mar 22, 1999
OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR,...
K990249 · CEP
Phamatech
Chemistry · 55d
Cleared Mar 22, 1999
ETEST MINOCYCLINE
K990297 · JWY
Ab Biodisk
Microbiology · 52d
Cleared Mar 22, 1999
KSEA ENDOSCOPE HOLDER
K990334 · OCV
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 47d
Cleared Mar 22, 1999
MOSS GASTROSTOMY TUBE
K990389 · KNT
Moss Tubes, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 22, 1999
ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05
K990393 · JJX
Bio-Rad
Chemistry · 41d
Cleared Mar 22, 1999
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.)
K990460 · JIX
Roche Diagnostics Corp.
Chemistry · 38d
Cleared Mar 22, 1999
IGM FLEX REAGENT CARTRIDGE
K990553 · CFQ
Dade Behring, Inc.
Immunology · 28d