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
141985–142008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 1986
POREX(TM) EAR PROSTHESIS
K863939 · FZD
Porex Medical
General & Plastic Surgery · 14d
Cleared Oct 24, 1986
POREX(TM) PROSTHESIS, CHIN, INTERNAL
K863941 · FWP
Porex Medical
General & Plastic Surgery · 14d
Cleared Oct 24, 1986
POREX(TM) NOSE PROSTHESIS
K863942 · FZE
Porex Medical
General & Plastic Surgery · 14d
Cleared Oct 24, 1986
P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL
K863950 · GDX
Precision Surgical Industries, Inc.
General & Plastic Surgery · 14d
Cleared Oct 24, 1986
P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE
K863951 · GDZ
Precision Surgical Industries, Inc.
General & Plastic Surgery · 14d
Cleared Oct 24, 1986
TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR GU
K863957 · FGE
Cathaid, Inc.
Gastroenterology & Urology · 14d
Cleared Oct 24, 1986
LIMB-GUARD
K863964
Sparco, Inc.
General & Plastic Surgery · 14d
Cleared Oct 24, 1986
OCEAN SCIENTIFIC VACUTEST
K863976 · JKA
Ocean Scientific, Inc.
Chemistry · 10d
Cleared Oct 24, 1986
VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY
K863982 · JCY
Vas-Cath of Canada , Ltd.
General & Plastic Surgery · 10d
Cleared Oct 24, 1986
ACCLAIM* BRACKET ADHESIVE
K864008 · DYH
Johnson & Johnson Professionals, Inc.
Dental · 9d
Cleared Oct 24, 1986
BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS
K864040 · FAE
C.R. Bard, Inc.
Gastroenterology & Urology · 8d
Cleared Oct 23, 1986
AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849
K852502 · IYO
Bruel & Kjaer Industri A/S
Radiology · 498d
Cleared Oct 23, 1986
SULKY SPECIAL
K863450 · LBE
Asc Corp.
Physical Medicine · 50d
Cleared Oct 23, 1986
UNIVERSAL CANNULA SYSTEM
K863590 · HRX
Aspen Laboratories, Inc.
Orthopedic · 38d
Cleared Oct 23, 1986
RE-HEATER, HOT PACK
K863654 · IME
K & L Ent.
Physical Medicine · 35d
Cleared Oct 23, 1986
SURGICAL DRAPE & DRAPE ACCESSORIES
K863732 · KKX
Intera Corp.
General Hospital · 30d
Cleared Oct 23, 1986
PULSESTAR EXERCISE BIKE
K863884 · ISD
Battle Creek Equipment Co.
Physical Medicine · 17d
Cleared Oct 23, 1986
THERACARE LOUNGER
K863892 · IOR
American Theracare
Physical Medicine · 17d
Cleared Oct 22, 1986
SUCTION CATHETER KIT
K861949 · BSY
Medi-Craft , Ltd.
Anesthesiology · 155d
Cleared Oct 22, 1986
DOUBLE LUMEN E T ADAPTOR
K862435 · BZA
Acutronic Medical Systems AG
Anesthesiology · 118d
Cleared Oct 22, 1986
STARCRAFT ELITE AUTOCLAVE
K862495 · FLE
Starcraft Medical Corp.
General Hospital · 113d
Cleared Oct 22, 1986
TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER
K862548 · BZT
Lawrence Medical Systems, Inc.
Anesthesiology · 111d
Cleared Oct 22, 1986
ASSERACHROM B-TG KIT
K862775 · JBX
American Bioproducts Co.
Hematology · 92d
Cleared Oct 22, 1986
PATHFINDER ROTAVIRUS CHEMILUMINESCENT
K862917 · LIQ
Kallestad Laboratories, Inc.
Microbiology · 82d