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
115249–115272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 1992
SURECATH PORT ACCESS CATHETER
K920036 · LJT
Ivion Corp.
General Hospital · 324d
Cleared Nov 25, 1992
ULTRA LOW POROSITY DACRON WOVEN PATCH
K921659 · DXZ
Intervascular, Inc.
Cardiovascular · 232d
Cleared Nov 25, 1992
MODEL 2000 DENTAL AIR ABRASIVE SYSTEM
K921748 · KOJ
Texas Airsonics, Inc.
Dental · 226d
Cleared Nov 25, 1992
ACCESS SURGICAL INT'L ENDOSCOPIC SURGICAL INSTRUM.
K922424 · GCJ
Access Surgical Intl., Inc.
General & Plastic Surgery · 188d
Cleared Nov 25, 1992
PROFEEL ANATOM SURG GLOVES (POWDER FREE/HYPOALLER)
K922515 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 182d
Cleared Nov 25, 1992
MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES
K922522 · FMF
Sherwood Medical Co.
General Hospital · 181d
Cleared Nov 25, 1992
SYMBIOSIS SUCTION-IRRIGATOR
K923563 · GEI
Symbiosis Corp.
General & Plastic Surgery · 131d
Cleared Nov 25, 1992
PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION
K923832 · DGC
Kabi Pharmacia, Inc.
Immunology · 120d
Cleared Nov 25, 1992
DEXIDE LAPAROSCOPIC ACCESSORIES
K923845 · GEI
Dexide, Inc.
General & Plastic Surgery · 117d
Cleared Nov 25, 1992
HERCULES MODEL 5060 AND 5100 ND:YAG LASER SYSTEMS
K923896 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 113d
Cleared Nov 25, 1992
NEEDLE
K924102 · FBK
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 104d
Cleared Nov 25, 1992
MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100
K924259 · JHI
Medix Biotech, Inc.
Chemistry · 93d
Cleared Nov 25, 1992
IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS)
K924360 · DYF
Impra, Inc.
Cardiovascular · 89d
Cleared Nov 25, 1992
ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP
K924373 · BZN
Instrumed, Inc.
Anesthesiology · 89d
Cleared Nov 25, 1992
EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415
K924572 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 76d
Cleared Nov 25, 1992
TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS
K924645 · JEX
Unitek Corp.
Dental · 72d
Cleared Nov 25, 1992
OLYMPUS BUN REAGENT
K924693 · CDQ
Olympus Corp.
Chemistry · 70d
Cleared Nov 25, 1992
3M CURING LIGHT XL 3000
K924812 · EBZ
3M Company
Dental · 61d
Cleared Nov 25, 1992
GLENROE BAND SEATING CONTOURING INSTRUMENT
K924993 · ECS
Glenroe Technologies
Dental · 55d
Cleared Nov 25, 1992
MCKERNAN ATRAUMATIC FORCEPS
K925041 · GCJ
Aslan Medical Technologies, Ltd.
General & Plastic Surgery · 51d
Cleared Nov 25, 1992
TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1
K925203 · JJQ
Heraeus Kulzer, Inc.
Chemistry · 97d
Cleared Nov 24, 1992
DIAL-A-RAD PORTA RAD TABLE
K913425 · IXQ
Dial-A-Rad
Radiology · 481d
Cleared Nov 24, 1992
INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE
K915696 · ITX
Interspec, Inc.
Radiology · 337d
Cleared Nov 24, 1992
BARD BILIARY BALLOON DILATORS
K920361 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 302d