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
86641–86664 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 1999
OMNICORDER, MODEL 464
K990027 · DSH
Del Mar Avionics
Cardiovascular · 35d
Cleared Feb 09, 1999
MEDTRONIC MODEL 7495 EXTENSION KIT
K990104 · GZB
Medtronic Vascular
Neurology · 28d
Cleared Feb 09, 1999
GE LOGIQ700 DIAGNOSTIC ULTRASOUND SYSTEM WITH B-FLOW
K990226 · IYO
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Feb 08, 1999
IQ SYSTEM
K981720 · DSB
Renaissance Technology, Inc.
Cardiovascular · 279d
Cleared Feb 08, 1999
MAX IT
K983438 · LKY
Dorea, Inc.
Gastroenterology & Urology · 132d
Cleared Feb 08, 1999
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
K983449 · BZQ
Gereonics, Inc.
Anesthesiology · 131d
Cleared Feb 08, 1999
HUMAN SERUM ALBUMIN (HSA)
K983584 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 118d
Cleared Feb 08, 1999
TRANSMYOMETRIAL EMBRYO TRANSFER SET
K983595 · MQF
Cook Ob/Gyn
Obstetrics & Gynecology · 118d
Cleared Feb 08, 1999
SYSTEM U3 FOR AMPICILLIN
K984087 · JWY
Ab Biodisk
Microbiology · 84d
Cleared Feb 08, 1999
AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE
K984280 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Feb 08, 1999
ELECYS IGE ASSAY
K984326 · JHR
Boehringer Mannheim Corp.
Immunology · 67d
Cleared Feb 08, 1999
QUANTA LITE GBM ELISA
K984336 · MVJ
Inova Diagnostics, Inc.
Immunology · 67d
Cleared Feb 08, 1999
ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000
K984405 · LMB
Intracom Corp.
Radiology · 61d
Cleared Feb 08, 1999
PHASED ARRAY FLEXIBLE CARDIAC COIL
K984588 · MOS
Philips Medical Systems (Cleveland),...
Radiology · 46d
Cleared Feb 08, 1999
CARESIDE AMYLASE
K990025 · JFJ
Careside, Inc.
Chemistry · 35d
Cleared Feb 08, 1999
IMAGEFUSION 2.0
K990071 · MUJ
Radionics, Inc.
Radiology · 28d
Cleared Feb 08, 1999
MILLENNIUM MLC -120
K990085 · IYE
Varian Assoc., Inc.
Radiology · 28d
Cleared Feb 05, 1999
QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO...
K982938 · DJR
Phamatech
Toxicology · 168d
Cleared Feb 05, 1999
VIRILIS PENILE PROSTHESIS
K983015 · FTQ
Specialty Surgical Products, Inc.
Gastroenterology & Urology · 161d
Cleared Feb 05, 1999
ACCU-CHEK HQ SYSTEM
K983047 · LFR
Boehringer Mannheim Corp.
Chemistry · 157d
Cleared Feb 05, 1999
OMNIFLATOR 7640 MODEL 7-640-00
K983326 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 136d
Cleared Feb 05, 1999
BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP
K983372 · DRS
Sunscope Intl., Inc.
Cardiovascular · 134d
Cleared Feb 05, 1999
INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING...
K983596 · MQH
Cook Ob/Gyn
Obstetrics & Gynecology · 115d
Cleared Feb 05, 1999
KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II
K983626 · DXH
Alaris Medical Systems, Inc.
Cardiovascular · 113d