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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
100321–100344 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 1995
NEEDLELESS INJECTION SITE
K953343 · FPA
Medical Associates Network, Inc.
General Hospital · 106d
Cleared Oct 26, 1995
SIMS CPAP SYSTEM
K953485 · BYE
Smiths Industries Medical Systems, Inc.
Anesthesiology · 94d
Cleared Oct 26, 1995
KENDALL SHERIDAN CPAP SYSTEM
K953511 · BYE
Kendall Healthcare Products Co....
Anesthesiology · 92d
Cleared Oct 26, 1995
UNSCENTED MENSTRUAL PAD
K953517 · HHD
Paragon Trade Brands, Inc.
Obstetrics & Gynecology · 91d
Cleared Oct 26, 1995
AXSYM PHENCYCLIDINE II
K953534 · LCM
Abbott Laboratories
Toxicology · 91d
Cleared Oct 26, 1995
SAS SALMONELLA O GROUP A ANTIGEN
K953841 · GNC
Sa Scientific, Inc.
Microbiology · 71d
Cleared Oct 26, 1995
SAS SALMONELLA H C ANTIGEN
K953842 · GNC
Sa Scientific, Inc.
Microbiology · 71d
Cleared Oct 26, 1995
SAS SALMONELLA O GROUP F ANTIGEN
K953843 · GNC
Sa Scientific, Inc.
Microbiology · 71d
Cleared Oct 26, 1995
SAS SALMONELLA VI ANTIGEN
K953844 · GNC
Sa Scientific, Inc.
Microbiology · 71d
Cleared Oct 26, 1995
SAS SALMONELLA O GROUP C ANTIGEN
K953846 · GNC
Sa Scientific, Inc.
Microbiology · 71d
Cleared Oct 26, 1995
SAS SALMONELLA O GROUP B ANTIGEN
K953848 · GNC
Sa Scientific, Inc.
Microbiology · 71d
Cleared Oct 26, 1995
LASESONICS LOW POWER CO2 LASER SYSTEM
K953917 · GEX
Heraeus Surgical, Inc.
General & Plastic Surgery · 66d
Cleared Oct 26, 1995
SPETZLER PIN
K954001 · HTY
Howmedica Corp.
Orthopedic · 62d
Cleared Oct 26, 1995
MICROSURGE PUNCTURE CLOSE DEVICE
K954072 · GCJ
Microsurge, Inc.
General & Plastic Surgery · 57d
Cleared Oct 26, 1995
DISPOSABLE FLEX TUBE
K954197 · BZA
Engstrom Medical
Anesthesiology · 50d
Cleared Oct 26, 1995
CHEMSTRIP MICRAL URINE TEST STRIPS
K954346 · JIR
Boehringer Mannheim Corp.
Chemistry · 38d
Cleared Oct 26, 1995
FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC
K954377 · FFL
Annex Medical, Inc.
Gastroenterology & Urology · 37d
Cleared Oct 25, 1995
AGEN DIMERTEST GOLD EIA
K945642 · GHH
Agen Biomedical , Ltd.
Hematology · 343d
Cleared Oct 25, 1995
CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY
K945838 · KPQ
Toshiba America Medical Systems, In.C
Radiology · 330d
Cleared Oct 25, 1995
PED ALERT
K950656 · IRN
Orbitec Technologies Corp.
Physical Medicine · 254d
Cleared Oct 25, 1995
SYNERGY TI ANTERIOR SPINAL SYSTEM
K950709 · KWQ
Cross Medical Products, Inc.
Orthopedic · 254d
Cleared Oct 25, 1995
DRIVING GLASSES
K951757 · HQY
Proview Optical Group Corp.
Ophthalmic · 191d
Cleared Oct 25, 1995
XKNIFE-3
K953482 · IYE
Radionics Software Applications, Inc.
Radiology · 93d
Cleared Oct 25, 1995
PHILIPS MULTI LEAF PRESCRIPTION ENTRY SYSTEM (MLP)
K953570 · IYE
Philips Medical Systems, Inc.
Radiology · 86d