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
129121–129144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 1989
APERTURE
K895084 · IZS
Custom Medical Products, Ltd.
Radiology · 74d
Cleared Oct 27, 1989
MODEL 2031 TMJ SURFACE COIL
K895131 · LNH
Medical Advances, Inc.
Radiology · 71d
Cleared Oct 27, 1989
BINDER SUBMALAR FACIAL IMPLANT II
K895152 · LZK
Implantech Associates, Inc.
General & Plastic Surgery · 78d
Cleared Oct 27, 1989
FORCE II
K895163 · DYH
American Orthodontics
Dental · 66d
Cleared Oct 27, 1989
FIRST MEDIC MODEL 610P
K895185 · LDD
First Medical Devices Corp.
Cardiovascular · 77d
Cleared Oct 27, 1989
FILMFAX
K895209 · LMD
Discovery Systems, Inc.
Radiology · 71d
Cleared Oct 27, 1989
CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER
K895231 · CAF
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 66d
Cleared Oct 27, 1989
RESPIRONICS INFANT BAGEASY
K895351 · BTM
Respironics, Inc.
Anesthesiology · 56d
Cleared Oct 27, 1989
SHILEY ELBOW 15MM SWIVEL CONNECTOR
K895388 · BZA
Shiley, Inc.
Anesthesiology · 58d
Cleared Oct 27, 1989
BUN (KINETIC)
K895666 · CDQ
Boehringer Mannheim Corp.
Chemistry · 37d
Cleared Oct 27, 1989
VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR
K895747 · CAP
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 31d
Cleared Oct 27, 1989
ENDOGUIDE PRODUCT LINE: EX0120, EX0300 AND EX0400
K895786 · GEX
Luxar Corp.
General & Plastic Surgery · 32d
Cleared Oct 27, 1989
DIRD INGANT O2 (BIO 2 HOOD)
K895866 · BYL
Bird Products Corp.
Anesthesiology · 23d
Cleared Oct 27, 1989
RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES
K895995 · LJM
Lipogen, Inc.
Immunology · 14d
Cleared Oct 27, 1989
FDP COLLECTION TUBES
K896033 · JCO
Medical Diagnostic Technologies, Inc.
Hematology · 11d
Cleared Oct 26, 1989
NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER
K893643 · DQA
Novametrix Medical Systems, Inc.
Anesthesiology · 164d
Cleared Oct 26, 1989
NEOS 02
K894240 · DXY
Biotronik Cardiac Pacemakers
Cardiovascular · 128d
Cleared Oct 26, 1989
DEFIB/PACING PADS
K894588 · DRO
Conmedcorp
Cardiovascular · 94d
Cleared Oct 26, 1989
PAQ10 PAPER CHART RECORDER
K894607 · DSF
Protocol Systems, Inc.
Cardiovascular · 98d
Cleared Oct 26, 1989
NON-INVASIVE BLOOD PRESSURE MODULE
K894945 · DXN
Marquette Electronics, Inc.
Cardiovascular · 84d
Cleared Oct 26, 1989
ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO.
K894991 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 79d
Cleared Oct 26, 1989
COORDINATOR
K895113 · LDD
Cardiotronics, Inc.
Cardiovascular · 72d
Cleared Oct 25, 1989
NIPRO SAFELET CATH
K894371 · FOZ
Pharma-Plast USA, Inc.
General Hospital · 100d
Cleared Oct 25, 1989
DYMAX ENDOVAGINAL BIOPSY GUIDE
K894415 · HGL
Dymax Corp
Obstetrics & Gynecology · 100d