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
129457–129480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 1989
ADX CANNABINOIDS
K890693 · LDJ
Abbott Laboratories
Toxicology · 196d
Cleared Aug 25, 1989
AD X(TM) ETHANOL
K890743 · DIC
Abbott Laboratories
Chemistry · 193d
Cleared Aug 25, 1989
ADX COCAINE METABOLITE
K890788 · DIO
Abbott Laboratories
Toxicology · 191d
Cleared Aug 25, 1989
MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE
K890988 · LDF
Pace Medical
Cardiovascular · 179d
Cleared Aug 25, 1989
DAMOR CREAM SATURATED DRESSING
K891097 · FRO
Damor America, Inc.
General & Plastic Surgery · 176d
Cleared Aug 25, 1989
EVERGOOD BRAND (PATIENT EXAM GLOVES-LATEX)
K891667 · LYY
San HU Chemical Industry Co., Ltd.
General Hospital · 158d
Cleared Aug 25, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892034 · LYY
Sistem Med-Pro (M) Sdn Bhd
General Hospital · 147d
Cleared Aug 25, 1989
LATEX EXAMINATION GLOVES, NON-STERILE
K892045 · LYY
C.N. Technocrats
General Hospital · 147d
Cleared Aug 25, 1989
CORRECT TOUCH EXAMINATION GLOVES (LATEX)
K892175 · LYY
Ampri Rubberware Industries Sdn Bhd
General Hospital · 142d
Cleared Aug 25, 1989
DISPOSABLE LATEX EXAMINATION GLOVES
K892179 · LYY
Rex Latex Products Co., Ltd.
General Hospital · 143d
Cleared Aug 25, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892413 · LYY
Beijing Jian Xing Latex Products Co.,...
General Hospital · 136d
Cleared Aug 25, 1989
PULSE TIME PRODUCTS LIMITED, PM-2
K892794 · DRT
Pulse Time Products, Ltd.
Cardiovascular · 130d
Cleared Aug 25, 1989
PULSE TIME PRODUCTS LIMITED, PM-3
K892795 · DRT
Pulse Time Products, Ltd.
Cardiovascular · 130d
Cleared Aug 25, 1989
EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.
K893561 · DSF
Edentec Corp.
Cardiovascular · 108d
Cleared Aug 25, 1989
MODIFIED MATERIAL USED IN INFUSION T
K893909 · FPA
Quinton, Inc.
General Hospital · 87d
Cleared Aug 25, 1989
MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS
K894055 · DXY
Medtronic Vascular
Cardiovascular · 79d
Cleared Aug 24, 1989
MOTILITY ORBITAL IMPLANT
K891137 · HPZ
Integrated Orbital Implants, Inc.
Ophthalmic · 174d
Cleared Aug 24, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892791 · IMM
Union Industrial Co., Ltd.
Physical Medicine · 135d
Cleared Aug 24, 1989
PATIENT EXAMINATION GLOVES (VINYL)
K892793 · LYY
Zest Mark Industrial Co., Ltd.
General Hospital · 126d
Cleared Aug 24, 1989
LATEX EXAMINATION GLOVES
K893346 · LYY
Avt Rubber Products , Ltd.
General Hospital · 126d
Cleared Aug 24, 1989
LATEX EXAMINATION GLOVES
K893492 · LYY
Modern Rubber Industrial Co., Ltd.
General Hospital · 112d
Cleared Aug 24, 1989
ELECTRONIC BLOOD PRESSURE MONITORS
K894062 · DXN
Hanson Scale Co.
Cardiovascular · 77d
Cleared Aug 24, 1989
CO2 SURGICAL LASER SYSTEM
K894074 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 77d
Cleared Aug 24, 1989
LATEX EXAMINATION GLOVES
K894197 · LYY
Medicare Industries, Inc.
General Hospital · 70d