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
97969–97992 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1996
ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511
K955093 · HGI
Utah Medical Products, Inc.
Obstetrics & Gynecology · 174d
Cleared Apr 29, 1996
SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE
K960040 · LFL
Sharplan Lasers, Inc.
General & Plastic Surgery · 118d
Cleared Apr 29, 1996
CLEARBLUE EASY
K960316 · LCX
Unipath , Ltd.
Chemistry · 97d
Cleared Apr 29, 1996
MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION
K960381 · IZH
Elscint, Inc.
Radiology · 94d
Cleared Apr 29, 1996
SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES
K960563 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 80d
Cleared Apr 29, 1996
SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE
K960657 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 73d
Cleared Apr 29, 1996
DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE...
K960815 · NAD
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 61d
Cleared Apr 29, 1996
MILL-ROSE BLIND MICROBIOLOGY BRUSH
K960880 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 56d
Cleared Apr 29, 1996
CARBOMEDICS MITRAL ROTATOR
K960923 · MOP
Carbomedics, Inc.
Cardiovascular · 54d
Cleared Apr 29, 1996
SALICYLATE ASSAY
K961131 · DKJ
Diagnostic Reagents, Inc.
Toxicology · 39d
Cleared Apr 26, 1996
LEVEL 1 BLOOD STREAM RECOVERY SYSTEM
K942844 · CAC
Level 1 Technologies, Inc.
Anesthesiology · 680d
Cleared Apr 26, 1996
CONSENSUS PCL SUBSITUTING TIBIAL INSERT
K953443 · JWH
U.S. Medical Products, Inc.
Orthopedic · 284d
Cleared Apr 26, 1996
NIL LATEX POWDERFREE EXAMINATION GLOVES
K955341 · LYY
Shangrila Latex Industries Pvt. , Ltd.
General Hospital · 157d
Cleared Apr 26, 1996
VARIANT ALPHA-THALASSEMIA SHORT PROGRAM
K955355 · GKA
Bio-Rad
Hematology · 157d
Cleared Apr 26, 1996
PREPOWDERED LATEX EXAMINATION GLOVES
K955888 · LYY
Pantai Utama Sdn. Bhd.
General Hospital · 119d
Cleared Apr 26, 1996
POWDERFREE LATEX EXAMINATION GLOVES
K955889 · LYY
Pantai Utama Sdn. Bhd.
General Hospital · 119d
Cleared Apr 26, 1996
DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS
K960103 · JIX
Dade Intl., Inc.
Chemistry · 106d
Cleared Apr 26, 1996
NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE...
K960279 · JWH
Zimmer, Inc.
Orthopedic · 98d
Cleared Apr 26, 1996
SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM
K960372 · HCH
Scanlan Intl., Inc.
Neurology · 91d
Cleared Apr 26, 1996
PLANCON MIRCOLAMELLAR KERATOME
K960395 · HNO
Plancon Instruments
Ophthalmic · 88d
Cleared Apr 26, 1996
MEDICATOR AEROSOL DRUG DELIVERY SYSTEM
K960397 · CAF
Healthline Medical
Anesthesiology · 88d
Cleared Apr 26, 1996
COMFIT ORTHOPEDIC
K960407 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 88d
Cleared Apr 26, 1996
WILSON-COOK BALLOON INFLATION DEVICE
K960415 · KNT
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Apr 26, 1996
COMFIT MICROPTIC
K960416 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 88d