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
122257–122280 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1991
INTEGO
K910904 · HQY
Racal Health & Safety, Inc.
Ophthalmic · 10d
Cleared Mar 14, 1991
TRABECULO-SUPRACHOROIDAL SHUNT
K902296 · KYF
Visionex, Inc.
Ophthalmic · 296d
Cleared Mar 14, 1991
HOWMEDICA HNR SYSTEM
K903563 · LWJ
Howmedica Corp.
Orthopedic · 219d
Cleared Mar 14, 1991
BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE
K905482 · GAM
Pfizer Hospital Products Group, Inc.
General & Plastic Surgery · 98d
Cleared Mar 14, 1991
ACE RECONSTRUCTIVE PLATE
K905595 · HRS
Ace Medical Co.
Orthopedic · 91d
Cleared Mar 14, 1991
FORCE 10, 20, 30, AND 40
K905605 · GEI
Valleylab, Inc.
General & Plastic Surgery · 90d
Cleared Mar 14, 1991
SUTURE APPLIER DEVICE
K905722 · MFJ
Laparomed Corp.
General & Plastic Surgery · 84d
Cleared Mar 14, 1991
LACRIMAL PLUG
K905750 · LZU
Tamcenan Corp.
Ophthalmic · 80d
Cleared Mar 14, 1991
SUNGLASSES (NON-PRESCRIPTION)
K905864 · HQY
The Limited Stores, Inc.
Ophthalmic · 84d
Cleared Mar 14, 1991
SUNGLASSES/NON-PRESCRIPTION (LA GIARDINIERA)
K910125 · HQY
The Limited Stores, Inc.
Ophthalmic · 66d
Cleared Mar 14, 1991
SUNGLASSES, NON-PRESCRIPTION (ITALO CREMONA)
K910126 · HQY
The Limited Stores, Inc.
Ophthalmic · 66d
Cleared Mar 14, 1991
SUNGLASSES, NON-PRESCRIPTION (POLINELLI)
K910127 · HQY
The Limited Stores, Inc.
Ophthalmic · 66d
Cleared Mar 14, 1991
EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE
K910527 · DJD
Syva Co.
Toxicology · 35d
Cleared Mar 13, 1991
RENALYZER PRX 90
K903034 · CGL
Swedish Trade Council USA
Chemistry · 245d
Cleared Mar 13, 1991
ON-SITE ALCOHOL
K903223 · DOJ
Toxi-Lab, Inc.
Toxicology · 233d
Cleared Mar 13, 1991
SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT
K905289 · FAD
Medical Engineering Corp.
Gastroenterology & Urology · 107d
Cleared Mar 13, 1991
MANHANDLER
K905381 · FPP
Lifeport, Inc.
General Hospital · 104d
Cleared Mar 13, 1991
MICROLINE SCREEN FOR OPIATES
K905491 · DJG
Drug Screening Systems, Inc.
Toxicology · 96d
Cleared Mar 13, 1991
PEDICRAFT INFANT REFLUX WEDGE
K905629 · FRP
Pedicraft, Inc.
General Hospital · 89d
Cleared Mar 13, 1991
INFANT REFLUX SLING
K905630 · FRP
Pedicraft, Inc.
General Hospital · 89d
Cleared Mar 13, 1991
VITAL-PORT(TM) M.R.I. VASCULAR ACCESS SYSTEM
K910005 · LJT
Med Institute, Inc.
General Hospital · 70d
Cleared Mar 13, 1991
DENTRONIX MODEL 2000
K910202 · KMH
Dentronix, Inc.
General Hospital · 62d
Cleared Mar 13, 1991
MTP TRANSPORT INFUSION PUMP, MODEL NO. MTPLEA
K910335 · FRN
Medical Technical Products
General Hospital · 47d
Cleared Mar 13, 1991
3M MODEL 8240 ITE HEARING AID
K910690 · ESD
3M Company
Ear, Nose, Throat · 22d