FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
113665–113688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 1993
BATTERY PACKS (VARIOUS MODELS)
K931200 · IZL
Access / God Loves You
Radiology · 126d
Cleared Jul 13, 1993
ELECTRIC TOOTH-BRUSH
K931360 · JEQ
U.S. Dentek Corp.
Dental · 118d
Cleared Jul 13, 1993
MICROVASIVE INSURG LAPTIE SUTURE LIGATOR
K931379 · HCF
Boston Scientific Corp
General & Plastic Surgery · 117d
Cleared Jul 13, 1993
GERITREX STERILE SALINE WET DRESSING
K931510 · FRO
Geritrex Corp.
General & Plastic Surgery · 109d
Cleared Jul 13, 1993
HE-30 GOLD
K931967 · DTR
Bentley Laboratories, Inc.
Cardiovascular · 83d
Cleared Jul 13, 1993
THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM
K932327 · KDQ
Davol, Inc.
General Hospital · 61d
Cleared Jul 13, 1993
PRECISION MED PRODUCTS, LTD. COAXIAL CIRCUITS
K932485 · CAI
Precision Med Products, Ltd.
Anesthesiology · 50d
Cleared Jul 13, 1993
PMP, LTD. PEDIATRIC ANESTHESIA CIRCUITS
K932487 · CAI
Precision Med Products, Ltd.
Anesthesiology · 50d
Cleared Jul 12, 1993
SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT I
K925453 · CBT
Sherwood Medical Co.
Anesthesiology · 257d
Cleared Jul 12, 1993
ARGYLE TURKEL SAFETY THORACENTESIS PROC. TRAY
K930847 · FMF
Sherwood Medical Co.
General Hospital · 144d
Cleared Jul 09, 1993
LATEX EXAMINATION GLOVES, MODIFICATION-NONPOWDERED
K915052 · LYY
Supertex Glove Intl. Corp.
General Hospital · 639d
Cleared Jul 09, 1993
O.R./SURGEONS GOWN, ITEM NO. 4951
K921151 · FYA
The Sewing Source, Inc.
General Hospital · 492d
Cleared Jul 09, 1993
O.R./SURGEONS GOWN, ITEM NO. 4952
K921152 · FYA
The Sewing Source, Inc.
General Hospital · 492d
Cleared Jul 09, 1993
O.R./SURGEONS GOWN, ITEM NO. 4960
K921153 · FYA
The Sewing Source, Inc.
General Hospital · 492d
Cleared Jul 09, 1993
O.R./SURGEONS GOWN, ITEM NO. 4962
K921154 · FYA
The Sewing Source, Inc.
General Hospital · 492d
Cleared Jul 09, 1993
O.R./SURGEONS GOWN, ITEM NO. 4962
K921155 · FYA
The Sewing Source, Inc.
General Hospital · 492d
Cleared Jul 09, 1993
O.R./SURGEONS GOWN, ITEM NO.4941
K921156 · FYA
The Sewing Source, Inc.
General Hospital · 492d
Cleared Jul 09, 1993
O.R./SURGEONS GOWN, ITEM NO. 4942
K921157 · FYA
The Sewing Source, Inc.
General Hospital · 492d
Cleared Jul 09, 1993
O.R./SURGEONS GOWN, ITEM NO. 4950
K921158 · FYA
The Sewing Source, Inc.
General Hospital · 492d
Cleared Jul 09, 1993
MORSE ANESTHESIA MANIFOLD
K921322 · FPA
Namic
General Hospital · 484d
Cleared Jul 09, 1993
ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION
K922766 · HTY
Acufex Microsurgical, Inc.
Orthopedic · 402d
Cleared Jul 09, 1993
CARDIO-PAK BASIC PUMP PACK
K923231 · DWE
Cardio-Med-Associates, Inc.
Cardiovascular · 373d
Cleared Jul 09, 1993
THE ELEVENTH FINGER
K923835 · GDF
Guardian Angel Products, Inc.
General & Plastic Surgery · 343d
Cleared Jul 09, 1993
ORIGIN BLUNT TIP SURGICAL TROCAR
K924011 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 333d