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
130657–130680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 1989
ABRAKADABRA - DENTAL ADHESIVE SYSTEM
K892003 · KLE
Parkell
Dental · 71d
Cleared Jun 07, 1989
HELENA THROMBOPLASTIN REAGENT
K892050 · GJS
Helena Laboratories
Hematology · 70d
Cleared Jun 07, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892099 · LYY
Tung Kuang Rubber Factory Co. , Ltd.
General Hospital · 65d
Cleared Jun 07, 1989
MODIFIED ULTIMA LITE
K892144 · EJT
Deringer-Ney, Inc.
Dental · 84d
Cleared Jun 07, 1989
CLA 200 CHEMPRO(R) LIPID ANALYZER
K892238 · CHH
Johnson & Johnson Professionals, Inc.
Chemistry · 64d
Cleared Jun 07, 1989
EASY-TEST IRON (IRON) ITEM NO. 16686
K892863 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Jun 07, 1989
LATEX DISPOSABLE EXAMINATION GLOVES
K892919 · LYY
Union Industrial Co., Ltd.
General Hospital · 56d
Cleared Jun 07, 1989
ARGENCO W
K893237 · EJT
Argen Precious Metals, Inc.
Dental · 40d
Cleared Jun 07, 1989
TRANS-ORAL DEPTH GAUGE
K893415 · LYQ
Ruggles Corp.
Orthopedic · 36d
Cleared Jun 06, 1989
OHMEDA 7800 ANESTHESIA VENTILATOR
K883159 · CBK
Ohmeda Medical
Anesthesiology · 316d
Cleared Jun 06, 1989
MODIFIED MRL NEUROPROBE SYSTEM V
K884869 · GZJ
Medical Research Laboratories, Inc.
Neurology · 197d
Cleared Jun 06, 1989
CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN
K884991 · BSZ
Datex Division Instrumentarium Corp.
Anesthesiology · 187d
Cleared Jun 06, 1989
MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER
K890497 · EWO
Monitor/Demlar
Ear, Nose, Throat · 125d
Cleared Jun 06, 1989
KDG ACETABULAR COMPONENT
K891262 · LWJ
Osteonics Corp.
Orthopedic · 90d
Cleared Jun 06, 1989
ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES
K891382 · GQL
Ortho Diagnostic Systems, Inc.
Microbiology · 89d
Cleared Jun 06, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891421 · LYY
Charone, Inc.
General Hospital · 84d
Cleared Jun 06, 1989
ACCUSPEC THYROID UPTAKE SYSTEM
K891466 · IZD
Nuclear Data, Inc.
Radiology · 83d
Cleared Jun 06, 1989
REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES
K891658 · LYY
Regent Hospital Products
General Hospital · 78d
Cleared Jun 06, 1989
PROLIFE PATIENT EXAMINATION GLOVES (LATEX)
K891660 · LYY
B J L Glove (M) Sdn. Bhd.
General Hospital · 78d
Cleared Jun 06, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891825 · LYY
J & T Medical Products Co., Ltd.
General Hospital · 74d
Cleared Jun 06, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891830 · LYY
Perindustrian Masmuar Sdn Bhd
General Hospital · 74d
Cleared Jun 06, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891832 · LYY
Integrasia Sdn Bhd
General Hospital · 71d
Cleared Jun 06, 1989
NIL PATIENT EXAMINATION GLOVES (LATEX)
K891834 · LYY
Glatex Sdn Bhd
General Hospital · 71d
Cleared Jun 06, 1989
RANK PATIENT EXAM GLOVES (MFG. INTER-CONTINENTAL)
K891843 · LYY
Worldwide Medical
General Hospital · 71d