Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
152953–152976 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 1984
AMER. MEDICAL PLASTICS CO 20100
K842492 · CAI
American Medical Plastics Co.
Anesthesiology · 10d
Cleared Jul 03, 1984
CEMENTLESS HIP PROSTHESIS
K840271
Mecron Medical Products, Inc.
Orthopedic · 162d
Cleared Jul 03, 1984
MULTICHANNEL 2000 FLUOROPTIC THERMOMET
K841105 · FLL
Luxtron
General Hospital · 111d
Cleared Jul 03, 1984
DENTAL COTTON ROLLS
K841327 · EFN
Intl. Verbandstoff-Fabrik Schaffhau
Dental · 92d
Cleared Jul 03, 1984
RIGHT ANGLED PICK
K841355 · JYT
Treace Medical, Inc.
Ear, Nose, Throat · 92d
Cleared Jul 03, 1984
MODEL 3014 SUCTION UNIT
K841631 · HHI
Forma Scientific, Inc.
Obstetrics & Gynecology · 74d
Cleared Jul 03, 1984
NEUROMEDICS ULTRASTIM 650-01
K841647 · IPF
Intermedics, Inc.
Physical Medicine · 74d
Cleared Jul 03, 1984
FALL-SAFE MONITOR
K841671 · KMI
Fsm Corp.
General Hospital · 71d
Cleared Jul 03, 1984
FALL-SAFE VEST
K841672 · KMI
Fsm Corp.
General Hospital · 71d
Cleared Jul 03, 1984
UTERINE INJECTOR 4.0MM
K841682 · HES
Humi Corp.
Obstetrics & Gynecology · 71d
Cleared Jul 03, 1984
SECURA SET
K841859 · FPA
Diatek, Inc.
General Hospital · 60d
Cleared Jul 03, 1984
DISPOS. POLY APRONS
K842016 · LDQ
Abco Dealers, Inc.
General & Plastic Surgery · 46d
Cleared Jul 03, 1984
SPOTTEST LACTOPHENOL COTTON BLUE STAIN
K842086 · JTO
Difco Laboratories, Inc.
Microbiology · 40d
Cleared Jul 03, 1984
EPIDURAL TRAYS
K842095 · CAZ
Concord Laboratories, Inc.
Anesthesiology · 39d
Cleared Jul 03, 1984
TISCHLER CERVICAL BIOPSY PUNCH FORCEPS
K842112 · HFB
J. Sklar Mfg. Co., Inc.
Obstetrics & Gynecology · 35d
Cleared Jul 03, 1984
LYFO-DISK MICROORGANISMS
K842129 · JTR
Micro-Bio-Logics
Microbiology · 35d
Cleared Jul 03, 1984
SURE & NATURAL MAXI-SHIELD
K842480 · HHD
Johnson & Johnson Professionals, Inc.
Obstetrics & Gynecology · 8d
Cleared Jul 02, 1984
CARDIO EXPRESS 100 HOLTER SCANNER
K840622 · DSI
Del Mar Avionics
Cardiovascular · 139d
Cleared Jul 02, 1984
ACS SOF-T GUIDE WIREE
K840795 · DQT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 130d
Cleared Jul 02, 1984
ARK TONGUE CLEANER
K841077 · LCN
Arkay Co.
Dental · 112d
Cleared Jul 02, 1984
GENERAL DIAGNOSTICS PLATELET ANTIBODY
K841465 · LLG
General Diagnostics
Immunology · 84d
Cleared Jul 02, 1984
STERILE O.R. BASIN KIT PRODUCT LINE
K841484 · FRG
Medline Industries, Inc.
General Hospital · 83d
Cleared Jul 02, 1984
10.5 FRENCH DILATOR, 15CM, W/LUER LOCK
K841995 · DRE
Quinton, Inc.
Cardiovascular · 48d
Cleared Jul 02, 1984
IDI ISOTONIC DILUENT
K842068 · GIF
Interscience Diagnostics, Inc.
Hematology · 40d