FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
161401–161424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 1982
STERILE ORTHOPEDIC STOCKINETTE
K812904 · LGF
Alba Health Care
Orthopedic · 91d
Cleared Jan 18, 1982
O.R. ARMBOARD COVER
K813030 · FWZ
Tecnol New Jersey Wound Care, Inc.
General & Plastic Surgery · 82d
Cleared Jan 18, 1982
LPM/50 MEMBRANE OXYGENATOR
K813255 · DTZ
Travenol Laboratories, S.A.
Cardiovascular · 60d
Cleared Jan 18, 1982
ADHESIVE STRIP(MULTIPLE)
K813361 · KGX
Cederroth, Inc. USA
General & Plastic Surgery · 49d
Cleared Jan 18, 1982
EXTERNAL BREAST PROSTHESIS
K813416 · GBI
Surgical Appliance Industries, Inc.
General & Plastic Surgery · 42d
Cleared Jan 18, 1982
SHEETS
K813551 · KKX
Lancaster County Assoc. For the Blind
General Hospital · 28d
Cleared Jan 18, 1982
PACE *AID
K813553 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 27d
Cleared Jan 18, 1982
GLUCOSE ENZYME-COLOR REAGENT SET
K813555 · CGA
Biorent Diagnostic, Inc.
Chemistry · 27d
Cleared Jan 18, 1982
CARDIOTRAC CORNING CK ISOENZYME SUBST
K813573 · JHX
Corning Medical & Scientific
Chemistry · 27d
Cleared Jan 18, 1982
LIQUID CHROMATOGRAPHY (HPLC) COLUMNS
K813575 · DPM
Supelco, Inc.
Toxicology · 26d
Cleared Jan 18, 1982
HEMOSTATIC SIDE-ARM ADAPTER
K813578 · DYG
Advanced Catheter Systems
Cardiovascular · 26d
Cleared Jan 18, 1982
Q-LINE LTC
K813580 · JJY
Miles Laboratories, Inc.
Chemistry · 25d
Cleared Jan 18, 1982
SHARTPOINT EYED NEEDLES
K813589 · GDL
S. Jackson, Inc.
General & Plastic Surgery · 21d
Cleared Jan 18, 1982
QUANTAFLUOR FLUORESCENT TEST REAGENTS
K813592 · DHN
Kallestad Laboratories, Inc.
Immunology · 21d
Cleared Jan 18, 1982
PARKE-DAVIS AEGIS ABOSRBENT SPONGES
K813595 · GDY
Deseret Medical, Inc.
General & Plastic Surgery · 21d
Cleared Jan 18, 1982
SILICONE ELASTOMER INFUSION CATHETER
K813606 · JCY
Quest Medical, Inc.
General & Plastic Surgery · 20d
Cleared Jan 15, 1982
INCISION & DRAINAGE TRAY
K812134 · FSM
E.M. Adams
General & Plastic Surgery · 171d
Cleared Jan 12, 1982
STEELE'S ECON. PINK BASEPL. WAXES, I-III
K812805 · EGD
Modern Materials
Dental · 98d
Cleared Jan 12, 1982
SCOTCHBOND DENTAL ADHESIVE
K813180 · KLE
3M Company
Dental · 61d
Cleared Jan 12, 1982
CRITIKON I.V. CATHETER PLACEMENT UNIT
K813345 · FOZ
Critikon Company, LLC
General Hospital · 48d
Cleared Jan 12, 1982
VERSCHLUBSTOPFEN COMB-CLOSING STOPPER
K813396 · FOZ
Burron Medical Products, Inc.
General Hospital · 39d
Cleared Jan 12, 1982
WA-2000 TEMPERATURE INDICATOR
K813402 · FLL
Wallach Surgical Devices, Inc.
General Hospital · 39d
Cleared Jan 12, 1982
ELECTROSURGICAL DISP. DISPERSIVE PAD
K813434 · KNS
Promedicon, Inc.
Gastroenterology & Urology · 35d
Cleared Jan 12, 1982
UNIT, LIQUID, OXYGEN, PORTABLE
K813453 · BYJ
Pensee Medical Corp.
Anesthesiology · 33d