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
131497–131520 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 1989
AVL MODEL 987 ELECTROLYTE ANALYZER
K891578 · CHL
Avl Scientific Corp.
Chemistry · 63d
Cleared May 22, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891638 · LYY
Tak Ent., Inc.
General Hospital · 66d
Cleared May 22, 1989
PATIENT EXAMINATION GLOVES (LATEX)(POWDERED)
K891640 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 66d
Cleared May 22, 1989
ESP RADIATION REDUCTION EXAMINATION GLOVES
K891968 · LZC
Boston Scientific Corp
General Hospital · 54d
Cleared May 22, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892093 · LYY
Wah Chiang Ent. Sdn Bhd
General Hospital · 49d
Cleared May 22, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892103 · LYY
Jenq Chuam Industrial Co., Ltd.
General Hospital · 49d
Cleared May 22, 1989
DRI-DYE CHECK STRIPS (TM)-405
K892656 · JJX
Awareness Technology, Inc.
Chemistry · 39d
Cleared May 22, 1989
NON-STERILE PATIENT EXAMINATION GLOVES (LATEX)
K892747 · LYY
Asia Way Trading, Inc.
General Hospital · 41d
Cleared May 22, 1989
ARGEDENT 45
K892814 · EJT
Argen Precious Metals, Inc.
Dental · 35d
Cleared May 22, 1989
AUTOTRANSFUSION DEVICE
K892819 · CAC
Impra, Inc.
Anesthesiology · 35d
Cleared May 22, 1989
T4 CLASP-BEAD EIA KIT
K892853 · KLI
Biotecx Laboratories, Inc.
Chemistry · 34d
Cleared May 22, 1989
ACA VANCOMYCIN (VANC) METHOD
K892900 · LEH
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 32d
Cleared May 22, 1989
ARGELITE 80SF+ DENTAL ALLOY
K892909 · EJT
Argen Precious Metals, Inc.
Dental · 32d
Cleared May 22, 1989
AMNIO-GROW TM
K892938 · KIT
Inovar Biologicals, Inc.
Pathology · 31d
Cleared May 22, 1989
MULTI PULSE POWER UNIT GENERATOR
K892943 · IZO
GE Medical Systems
Radiology · 31d
Cleared May 19, 1989
FORTEC MI-150 DIGITAL BLOOD PRESSURE METER
K884405 · DXN
Nam Tai Electronic & Electrical...
Cardiovascular · 211d
Cleared May 19, 1989
THE COACH
K884804 · DRT
Promark, Inc.
Cardiovascular · 183d
Cleared May 19, 1989
E-Z-FLOW ANGIOGRAPHY CATHETERS
K890206 · DQO
E-Z-Em, Inc.
Cardiovascular · 122d
Cleared May 19, 1989
HIGH PRESSURE CONNECTING SETS
K890208 · DXT
E-Z-Em, Inc.
Cardiovascular · 122d
Cleared May 19, 1989
DISPOSABLE ANGIOGRAPHY NEEDLES
K890209 · DRC
E-Z-Em, Inc.
Cardiovascular · 122d
Cleared May 19, 1989
PERSONAL ALERT ASSIST DEVICE
K890445 · LXI
Silent Call Corp.
Orthopedic · 112d
Cleared May 19, 1989
INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA
K890525 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 106d
Cleared May 19, 1989
KENDALL SCD THERAPEUTIC SYSTEM
K890938 · JOW
Kendall Healthcare Products Co....
Cardiovascular · 84d
Cleared May 19, 1989
MODIFIED EXTERNAL PAD
K891000 · DWS
Instromedix, Inc.
Cardiovascular · 81d