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
130345–130368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 1989
ARGENCO 68 TYPE IV DENTAL GOLD ALLOY
K893565 · EJT
Argen Precious Metals, Inc.
Dental · 45d
Cleared Jun 23, 1989
ARGENCO 56 TYPE IV DENTAL GOLD ALLOY
K893568 · EJT
Argen Precious Metals, Inc.
Dental · 45d
Cleared Jun 23, 1989
ACTICHROME ATIII KIT
K893608 · JBQ
American Diagnostic Corp.
Hematology · 44d
Cleared Jun 23, 1989
VISTA MR 2055 HP SYSTEM
K893619 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 44d
Cleared Jun 23, 1989
MODIFIED STERILIZATION OF TUR APRONS
K893634 · FXX
Brant-Wald Surgicals, Inc.
General Hospital · 43d
Cleared Jun 23, 1989
PLATELET AGGREGATION PROFILER MODEL PAP-4C
K893650 · JPA
Bio/Data Corp.
Hematology · 39d
Cleared Jun 23, 1989
RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60
K893652 · IYB
Fischer Imaging Corp.
Radiology · 39d
Cleared Jun 23, 1989
RADIOGRAPHIC CEILING TUBE SUPPORT CTS15
K893653 · IYB
Fischer Imaging Corp.
Radiology · 39d
Cleared Jun 23, 1989
MEMORY CHAIN
K893654 · EJF
American Orthodontics
Dental · 39d
Cleared Jun 23, 1989
CELLMATICS SHLAMYDIA DETECTION SYSTEM
K893669 · LKH
Difco Laboratories, Inc.
Microbiology · 39d
Cleared Jun 23, 1989
ARGELOY N.P.
K893686 · EJT
Argen Precious Metals, Inc.
Dental · 38d
Cleared Jun 23, 1989
TECNOL GAITERS PRODUCT NUMBER 47725-010
K893702 · FXP
Tecnol New Jersey Wound Care, Inc.
General Hospital · 36d
Cleared Jun 23, 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I
K893783 · GIZ
Analytical Control Systems, Inc.
Hematology · 32d
Cleared Jun 23, 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I
K893784 · GIZ
Analytical Control Systems, Inc.
Hematology · 32d
Cleared Jun 23, 1989
LIFECELL RECOVERY CONTAINER
K893787 · KJF
Baxter Healthcare Corp
Pathology · 32d
Cleared Jun 23, 1989
BREATHING MOUTHPIECE
K893791 · BYP
Diemolding Corp.
Anesthesiology · 32d
Cleared Jun 23, 1989
ACCESS TM
K893881 · LNH
Diasonics, Inc.
Radiology · 28d
Cleared Jun 23, 1989
SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM
K893897 · LKJ
Biostar Medical Products, Inc.
Immunology · 24d
Cleared Jun 22, 1989
SEER
K882818 · DSI
Marquette Electronics, Inc.
Cardiovascular · 349d
Cleared Jun 22, 1989
ACTA GENOS ELECTROCARDIOGRAPH
K884800 · DPS
Parexel Intl. Corp.
Cardiovascular · 218d
Cleared Jun 22, 1989
SELBY INSTRUMENTATION
K884998 · KWP
Advanced Spine Fixation Systems, Inc.
Orthopedic · 202d
Cleared Jun 22, 1989
SURGICAL GLOVES
K885089 · KGO
Wb Intl., Inc.
General Hospital · 192d
Cleared Jun 22, 1989
OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES)
K885102 · LZO
Osteonics Corp.
Orthopedic · 192d
Cleared Jun 22, 1989
APR COLLARED REVISION FEMORAL COMPONENT
K885192 · JDI
Intermedics Orthopedics
Orthopedic · 188d