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
129457–129480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1989
ACCESS CHEMISTRY ANALYZER
K895423 · JJE
American Monitor Corp.
Chemistry · 27d
Cleared Oct 04, 1989
NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL
K895474 · HKI
Canon USA, Inc.
Ophthalmic · 23d
Cleared Oct 04, 1989
STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.
K895484 · LCD
Baxter Healthcare Corp
Toxicology · 23d
Cleared Oct 04, 1989
QCLYTE PROTEIN-BASED ISE CONTROL
K895582 · JJR
Baxter Healthcare Corp
Chemistry · 19d
Cleared Oct 04, 1989
NIL PATIENT EXAMINATION GLOVES
K895641 · LYY
United Lion Rubber Industries Sdn. Bhd.
General Hospital · 15d
Cleared Oct 03, 1989
ERGOMED 840/ERGOMED 840L
K885085 · DRT
Burdick Corp.
Cardiovascular · 298d
Cleared Oct 03, 1989
SYRINGE INJECTION GUN DELIVERY KITS
K890658 · LRO
Gastrotech, Inc.
General & Plastic Surgery · 237d
Cleared Oct 03, 1989
BIOPSY FORCEPS
K892252 · FCL
Zinnanti Surgical Instruments, Inc.
Gastroenterology & Urology · 182d
Cleared Oct 03, 1989
MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR
K892396 · BXN
Biometer Intl. A/S
Anesthesiology · 179d
Cleared Oct 03, 1989
BAXTER ACETONE-ALCOHOL PREP PADS, STERILE
K893958 · LKB
Span-America Medical Systems, Inc.
General Hospital · 124d
Cleared Oct 03, 1989
THERMOSURGERY TM
K894166 · GEI
Rdm Intl., Inc.
General & Plastic Surgery · 110d
Cleared Oct 03, 1989
GX-ELEVATOR
K894188 · IZZ
Gendex Corp.
Radiology · 109d
Cleared Oct 03, 1989
MEDICAL DYNAMICS LIGHT SOURCE
K894319 · FSW
Medical Dynamics, Inc.
General & Plastic Surgery · 81d
Cleared Oct 03, 1989
SALTER LABS MODEL #4009 SAMPLE LINES
K894350 · CCK
Salter Labs
Anesthesiology · 81d
Cleared Oct 03, 1989
VAS-CATH URETERAL STENT CATHETER
K894357 · FAD
Vas-Cath, Inc.
Gastroenterology & Urology · 81d
Cleared Oct 03, 1989
ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT
K894394 · CFR
Abbott Laboratories
Chemistry · 78d
Cleared Oct 03, 1989
THERMALGRAPHIC ANALYSER
K894772 · HCS
Medtech Instruments
Neurology · 69d
Cleared Oct 03, 1989
BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE
K894791 · LKB
Span-America Medical Systems, Inc.
General Hospital · 67d
Cleared Oct 03, 1989
CARDIOBEEPER MEMORY MONITOR CB 600 SERIES
K894799 · DXH
Survival Technology, Inc.
Cardiovascular · 67d
Cleared Oct 03, 1989
PEDI-TUBE(R) STYLET
K894857 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 64d
Cleared Oct 03, 1989
SELECTRODE
K894920 · DRX
S & W Medico Teknik
Cardiovascular · 62d
Cleared Oct 03, 1989
STERILE SALINE - FOR SUCTION CATHETER LUBRICATION
K895039 · GCX
Aplicare, Inc.
General Hospital · 55d
Cleared Oct 03, 1989
ADD'L OPTIONS 1.5 TESLA & 1.0 TESLA TO MAGNETOM 42
K895221 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 67d
Cleared Oct 03, 1989
VALPROIC ACID (FPIA) KIT
K895569 · LEG
Tudor Laboratories, Inc.
Toxicology · 27d