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
130009–130032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 1989
LATEX EXAMINATION GLOVES
K894324 · LYY
M/S Overseas Latex Pvt. , Ltd.
General Hospital · 46d
Cleared Aug 29, 1989
LATEX PATIENT EXAMINATION GLOVES
K894773 · LYY
Transrich Industries Sdn. Bhd.
General Hospital · 34d
Cleared Aug 29, 1989
DMI 250 SERIES POWER SURGERY TABLE
K894789 · JEA
M.D. Intl., Inc.
General & Plastic Surgery · 32d
Cleared Aug 28, 1989
DANEK WRIST FIXATOR
K891066 · KTT
Danek Medical, Inc.
Orthopedic · 180d
Cleared Aug 28, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892047 · LYY
Gainlite Co., Ltd.
General Hospital · 150d
Cleared Aug 28, 1989
MULTI-DRUG(TM) INFUSION SYSTEM
K892210 · FRN
I-Flow Corp.
General Hospital · 147d
Cleared Aug 28, 1989
RCI VIRAL/BACTERIAL FILTER
K892230 · CAH
Respiratory Care, Inc.
General Hospital · 146d
Cleared Aug 28, 1989
DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM
K892370 · DXH
Bio-Focus, Inc.
Cardiovascular · 144d
Cleared Aug 28, 1989
TOMAX ULTRASCAN
K892653 · IZF
Incubation Industries, Inc.
Radiology · 137d
Cleared Aug 28, 1989
STATSPIN MINI-PLASMA
K893613 · JKA
Statspin Technologies
Chemistry · 110d
Cleared Aug 28, 1989
HOBBS MEDICAL MICROBIOLOGY BRUSH
K893729 · FDX
Hobbs Medical, Inc.
Gastroenterology & Urology · 103d
Cleared Aug 28, 1989
COUGH PILLOW
K893809 · KMO
Custom Hospitals Products
General Hospital · 98d
Cleared Aug 28, 1989
EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410
K893916 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 90d
Cleared Aug 28, 1989
EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421
K893917 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 90d
Cleared Aug 28, 1989
THERA-MIST(TM) NEBULIZER, MODEL 30000
K893942 · CAF
Pegasus Research Corp.
Anesthesiology · 89d
Cleared Aug 28, 1989
THERA-MIST HUMIDIFIER
K894000 · BTT
Pegasus Research Corp.
Anesthesiology · 84d
Cleared Aug 28, 1989
WATER PIK(R)
K894015 · EFS
Teledyne Water Pik
Dental · 83d
Cleared Aug 28, 1989
IVAC(R) SPACE.SAVER(TM) VOLUMETRIC PUMP MODEL 599
K894037 · FRN
Y
General Hospital · 83d
Cleared Aug 28, 1989
PUMP-JECT SYRINGE WITH LUER-LOCK
K894041 · FRN
Ziehm International, Inc.
General Hospital · 83d
Cleared Aug 28, 1989
PREMIER-TOTAL HIP
K894051 · LWJ
Intermedics Orthopedics
Orthopedic · 82d
Cleared Aug 28, 1989
VERICORD S3
K894123 · IYE
Philips Medical Systems, Inc.
Radiology · 77d
Cleared Aug 28, 1989
POWER EXAMINATION TABLE MODEL # 411
K894134 · LGX
Midmark Corp.
General Hospital · 76d
Cleared Aug 28, 1989
POWER EXAMINATION TABLE MODEL # 405
K894144 · LGX
Midmark Corp.
General Hospital · 76d
Cleared Aug 28, 1989
CK-MB/LD-1 CONTROL SYSTEM
K894207 · JJT
Boehringer Mannheim Corp.
Chemistry · 70d