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
130825–130848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 1989
MULTIPHASE ORTHODONTIC WIRE
K893484 · EJF
American Orthodontics
Dental · 71d
Cleared Jul 14, 1989
LAPAROSCOPIC SUCTION PROBE
K893527 · JOL
Dexide, Inc.
General Hospital · 67d
Cleared Jul 14, 1989
PLASTIC FORCE MODULE
K893550 · EJF
American Orthodontics
Dental · 67d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES
K893551 · LYY
Mlb Holdings Sdn. Bhd.
General Hospital · 67d
Cleared Jul 14, 1989
X-RING AND SPEED STIX PLASTIC LIGATURES
K893555 · EJF
American Orthodontics
Dental · 67d
Cleared Jul 14, 1989
A.QC HCT LEVEL 1 AND 2
K893562 · GLK
Johnson & Johnson Professionals, Inc.
Hematology · 66d
Cleared Jul 14, 1989
ARGENCO 50 TYPE IV TYPE IV DENTAL GOLD ALLOY
K893566 · EJT
Argen Precious Metals, Inc.
Dental · 66d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES
K893594 · LYY
Glovetex Industries
General Hospital · 66d
Cleared Jul 14, 1989
REMOVE ADHESIVE REMOVER
K893603 · KOX
Smith & Nephew United, Inc.
General & Plastic Surgery · 59d
Cleared Jul 14, 1989
BARD PLAQUE ELECTRODE ARRAY
K893611 · DRF
Bard Electrophysiology
Cardiovascular · 65d
Cleared Jul 14, 1989
MOBILE C-ARM
K893617 · OXO
Acoma Medical Imaging, Inc.
Radiology · 65d
Cleared Jul 14, 1989
MODIFIED ENDOGUIDE
K893642 · GEX
Luxar Corp.
General & Plastic Surgery · 60d
Cleared Jul 14, 1989
ELECTROSURGERY ANALYZER RF302
K893659 · GEI
Bio-Tek Instruments, Inc.
General & Plastic Surgery · 60d
Cleared Jul 14, 1989
VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES
K893675 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 59d
Cleared Jul 14, 1989
ASPEN DISPOSABLE BIPOLAR CORD
K893732 · GEI
Conmedcorp
General & Plastic Surgery · 58d
Cleared Jul 14, 1989
VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES
K893739 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 58d
Cleared Jul 14, 1989
CEFIXIME, 5 MCG SENSI-DISC ANTIMIC SUSCEP TEST DIS
K893754 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 56d
Cleared Jul 14, 1989
MODELS 1113 AND 1114 PACEMAKER LEADS
K893763 · DTB
Possis Medical, Inc.
Cardiovascular · 56d
Cleared Jul 14, 1989
PATIENT EXAMINATION GLOVES W/CORN STARCH POWDER
K893782 · LYY
Rubberex (M) Sdn Berhad
General Hospital · 53d
Cleared Jul 14, 1989
FLOOR STANDING, OPERATING AND EXAMINING LIGHT
K893813 · FSS
Astralite Corp.
General & Plastic Surgery · 52d
Cleared Jul 14, 1989
ADAMS BREAST IMPLANT PROTECTOR
K893870 · GCZ
Adept-Med Intl., Inc.
General & Plastic Surgery · 49d
Cleared Jul 14, 1989
QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA
K893896 · LKJ
Biostar Medical Products, Inc.
Immunology · 45d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES
K893901 · LYY
Tillotson Corp.
General Hospital · 45d
Cleared Jul 14, 1989
4 X 4 STERILE GAUZE SPONGE TRAY
K893902 · EFQ
Mumtaz I. Malik
General & Plastic Surgery · 45d