FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
131545–131568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 1989
SCOPIX LASER IMAGER
K891924 · LMC
Enhanced Imaging Technologies, Inc.
Radiology · 52d
Cleared May 18, 1989
QCT-LUNG NODULE (TM) ANALYSIS PACKAGE
K891931 · JAK
Image Analysis, Inc.
Radiology · 51d
Cleared May 18, 1989
Q5000 PC WORKSTATION
K892113 · DQK
Quinton, Inc.
Cardiovascular · 66d
Cleared May 18, 1989
PULMONARY RESUSCITATOR, MODIFICATION
K892221 · BTM
Life Design Systems, Inc.
Anesthesiology · 49d
Cleared May 18, 1989
ARGEDENT 75
K892234 · EJT
Argen Precious Metals, Inc.
Dental · 44d
Cleared May 18, 1989
DENTAL HAND INSTRUMENTS
K892239 · EKJ
Implant Support Systems, Inc.
Dental · 84d
Cleared May 18, 1989
NEW AM-SERIES DIALYZERS
K892374 · FJI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 48d
Cleared May 18, 1989
MODIFIED AM-SERIES DIALYZERS
K892375 · FJI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 48d
Cleared May 18, 1989
SUCTION TUBES: HOUSE, BARON
K892549 · GCX
Zinnanti Surgical Instruments, Inc.
General Hospital · 37d
Cleared May 18, 1989
PERITONEAL DIALYSIS CYCLER SET, W/5 PRONG MANIFOLD
K892870 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 29d
Cleared May 18, 1989
PERITONEAL DIALYSIS CYCLER SET, W/8 PRONG MANIFOLD
K892871 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 29d
Cleared May 18, 1989
PERITONEAL DIALYSIS CYCLER SET W/12 PRONG MANIFOLD
K892872 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 29d
Cleared May 17, 1989
MCDONALD FOLDING FORCEPS
K885230 · HNR
Alcon Laboratories
Ophthalmic · 148d
Cleared May 17, 1989
LACRIMAL EFFICIENCY TEST (TM)
K890714 · LZU
Lacrimedics, Inc.
Ophthalmic · 93d
Cleared May 17, 1989
WOODLYN OPHTHALMIC PROJECTOR
K890992 · HOS
Woodlyn, Inc.
Ophthalmic · 79d
Cleared May 17, 1989
FETAL HEMOGLOBIN
K892241 · GHQ
Sure-Tech Diagnostic Associates, Inc.
Hematology · 56d
Cleared May 17, 1989
NOVA GEL(TM) JO-1
K892897 · LLL
Inova Diagnostics, Inc.
Immunology · 27d
Cleared May 17, 1989
SITE PERISTALTIC CASSETTE
K892911 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 27d
Cleared May 16, 1989
DRI-VENT ARTERIAL BLOOD SAMPLING KIT
K883840 · LKB
Concord Laboratories, Inc.
General Hospital · 246d
Cleared May 16, 1989
MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU.
K884151 · LDS
Miele Appliances, Inc.
General Hospital · 225d
Cleared May 16, 1989
PH BLOOD GAS CONTROL PRODUCTS
K884266 · JPK
Alko Diagnostic Corp.
Chemistry · 217d
Cleared May 16, 1989
KITCHIN DENTAL ABCESS DRAIN
K885231 · EIE
Kitchin, Inc.
Dental · 147d
Cleared May 16, 1989
ACUSON S228 TRANSDUCER FOR TRANSCRANIAL DOPPLER
K890055 · IYN
Acuson Corp.
Radiology · 130d
Cleared May 16, 1989
THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION
K890407 · HIS
Circle Rubber Corp.
Obstetrics & Gynecology · 112d