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
146665–146688 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 1985
IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C
K851828 · MOT
Syncor Intl. Corp.
Radiology · 146d
Cleared Sep 19, 1985
FUKUDA DENSHI MODEL AU-5001-5003 THERMAL
K852487 · DSF
Fukuda Denshi USA, Inc.
Cardiovascular · 100d
Cleared Sep 19, 1985
5.0 MHZ LINEAR ARRAY, MODEL 83, 39, 517
K852570 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 93d
Cleared Sep 19, 1985
3.5 MHZ LINEAR ARRAY, MODEL NO. 83, 39, 509
K852571 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 93d
Cleared Sep 19, 1985
3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802
K852572 · JAF
Siemens Medical Solutions USA, Inc.
Radiology · 93d
Cleared Sep 19, 1985
FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20)
K852606 · FPA
Infarkem Corp.
General Hospital · 92d
Cleared Sep 19, 1985
FOR USE IN GENERAL & PLASTIC SURGERY & DERMATOLOGY
K852696 · GEX
Minnesota Laser Corp.
General & Plastic Surgery · 85d
Cleared Sep 19, 1985
TEGADERM PLUS TRANSPARENT DRESSING #952X
K852750 · FRO
3M Company
General & Plastic Surgery · 84d
Cleared Sep 19, 1985
ORALIX PANORAMIC D.C.
K852768 · IZF
Philips Medical Systems, Inc.
Radiology · 83d
Cleared Sep 19, 1985
ALLERCOAT ALLERGEN DISCS
K852794 · DHB
Kallestad Laboratories, Inc.
Immunology · 80d
Cleared Sep 19, 1985
BIOCHRON FERTILITY INDICATOR
K852801 · LHD
Fertil-A-Chron, Inc.
Obstetrics & Gynecology · 80d
Cleared Sep 19, 1985
NON-KOR ACCESS KITS
K852831 · FMI
Creative Care Systems, Inc.
General Hospital · 79d
Cleared Sep 19, 1985
SELECTICULT-CHLAMYDIA
K852869 · LKH
Scott Laboratories, Inc.
Microbiology · 73d
Cleared Sep 19, 1985
SIEMENS MEVATRON ME
K852907 · LHN
Siemens Medical Laboratories, Inc.
Radiology · 72d
Cleared Sep 19, 1985
DYNA GARD SYRINGE FILTER
K852996 · FPB
Microgon, Inc.
General Hospital · 66d
Cleared Sep 19, 1985
IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED
K853122 · GMS
Immuno-Products Industries
Microbiology · 56d
Cleared Sep 19, 1985
FLOW EASE(PLASTIC VENTED NEEDLE)
K853212 · LHI
Acacia, Inc.
General Hospital · 50d
Cleared Sep 19, 1985
MINI-HALO(HAND-HELD) CO2 LASER SYSTEM
K853319 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 43d
Cleared Sep 19, 1985
AUTO PRO
K853378 · NFB
Respiration Technology, Inc.
Anesthesiology · 38d
Cleared Sep 19, 1985
THE KEYMED VARI-HEIGHT PATIENT COUCH
K853421 · FPO
Keymed, Inc.
General Hospital · 36d
Cleared Sep 19, 1985
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES
K853456 · DHB
Pharmacia, Inc.
Immunology · 34d
Cleared Sep 19, 1985
YSI MODEL 790 TELE-THERMOMETER
K853551 · FLL
Yellow Springs Instrument Co., Inc.
General Hospital · 24d
Cleared Sep 19, 1985
INFLATABLE AIR SPLINTS
K853600 · FZF
Hospitak, Inc.
General & Plastic Surgery · 23d
Cleared Sep 19, 1985
NITTO SURGICAL PLASTIC TAPE ST-356
K853644 · KGX
Nitto Denko America, Inc.
General & Plastic Surgery · 16d