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
130033–130056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 1989
PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735)
K894230 · IYE
Siemens Medical Laboratories, Inc.
Radiology · 70d
Cleared Aug 28, 1989
URIC ACID TEST ITEM NUMBER 65422
K894287 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 66d
Cleared Aug 28, 1989
ABUSCREEN POSITIVE REFERENCE CONTROLS
K894464 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 39d
Cleared Aug 28, 1989
FPR CARBAMAZEPINE KIT
K894519 · KLT
Colony Laboratories, Inc.
Toxicology · 39d
Cleared Aug 28, 1989
FPR CARBAMAZEPINE CALIBRATOR KIT
K894520 · DLJ
Colony Laboratories, Inc.
Toxicology · 39d
Cleared Aug 28, 1989
FPR PHENOBARBITAL KIT
K894525 · LGQ
Colony Laboratories, Inc.
Toxicology · 39d
Cleared Aug 28, 1989
FPR PHENOBARBITAL CALIBRATOR KIT
K894526 · DLJ
Colony Laboratories, Inc.
Toxicology · 39d
Cleared Aug 25, 1989
HOME BLOOD PRESSURE KIT, ANEROID
K884420 · DXY
Yamasu Co. , Ltd.
Cardiovascular · 309d
Cleared Aug 25, 1989
MODEL 5650 OPTIMATE PERSONAL PROGRAMMER
K884522 · KRG
Teletronics, Inc.
Cardiovascular · 302d
Cleared Aug 25, 1989
ADX TM PHENCYCLIDINE
K890688 · LCM
Abbott Laboratories
Toxicology · 192d
Cleared Aug 25, 1989
ADX TM OPIATES
K890689 · DGJ
Abbott Laboratories
Toxicology · 192d
Cleared Aug 25, 1989
ADX TM BARBITURATES
K890690 · DIS
Abbott Laboratories
Toxicology · 192d
Cleared Aug 25, 1989
ADX TM BENZODIAZEPINES
K890691 · JXM
Abbott Laboratories
Toxicology · 192d
Cleared Aug 25, 1989
ADX AMPHETAMINE/METHAMPHEAMINE
K890692 · DKZ
Abbott Laboratories
Toxicology · 196d
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