FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
87553–87576 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 24, 1998
UNIPOLAR OPTICAL BIOPSY FORCEPS
K983811 · KGE
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 57d
Cleared Dec 23, 1998
PROGUARD, RR-1, RR-2
K982832 · LZC
Emerson & Co. Srl
General Hospital · 133d
Cleared Dec 23, 1998
POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50...
K982897 · LYY
Pt. Maja Agung Latexindo
General Hospital · 128d
Cleared Dec 23, 1998
TRIP TONOMETRY CATHETER, 16F
K983366 · KNT
Datex-Engstrom, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 23, 1998
AGATHA-A-H2010
K983374 · EFS
Midian Intl.
Dental · 89d
Cleared Dec 23, 1998
SYSTEM U3 FOR NORFLOXACIN
K983486 · JWY
Ab Biodisk
Microbiology · 79d
Cleared Dec 23, 1998
POSITRON OPTION, MODEL NSCO-050A
K983514 · KPS
Toshiba America Medical Systems, In.C
Radiology · 77d
Cleared Dec 23, 1998
TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A
K983516 · KPS
Toshiba America Medical Systems, In.C
Radiology · 77d
Cleared Dec 23, 1998
MICRO DYNAMIC MESH
K983528 · JEY
Howmedica Corp.
Dental · 76d
Cleared Dec 23, 1998
SOLARTEC SOURCE 270, MODEL # 90123
K983714 · FFS
Cogent Light Technologies, Inc.
Gastroenterology & Urology · 63d
Cleared Dec 23, 1998
VITALCARE DISPOSABLE VAGINAL SPECULUM
K983716 · HIB
Vitalcare Group, Inc.
Obstetrics & Gynecology · 63d
Cleared Dec 23, 1998
SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
K984014 · JIX
Beckman Coulter, Inc.
Chemistry · 42d
Cleared Dec 23, 1998
POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELLING...
K984019 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 41d
Cleared Dec 23, 1998
POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150...
K984020 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 41d
Cleared Dec 23, 1998
OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT
K984145 · DDR
Olympus Diagnostica GmbH
Immunology · 34d
Cleared Dec 23, 1998
MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM
K984211 · HIB
Medscand AB
Obstetrics & Gynecology · 29d
Cleared Dec 23, 1998
AIA-PACK TROPONIN I ASSAY
K984359 · MMI
Tosoh Medics, Inc.
Chemistry · 16d
Cleared Dec 23, 1998
6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497
K984384 · CHL
Thermo Bioanalysis Corp.
Chemistry · 15d
Cleared Dec 23, 1998
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K984500 · DYB
Cordis Corp.
Cardiovascular · 6d
Cleared Dec 22, 1998
PHUSIS ABSORBABLE INTERFERENCE SCREW
K970829 · HWC
Tornier
Orthopedic · 656d
Cleared Dec 22, 1998
LS SERIES 200 FLOVISION SYSTEM
K971981 · CAF
Systam
Anesthesiology · 572d
Cleared Dec 22, 1998
CROSSLAPS ELISA
K972788 · JMM
Devices and Diagnostics Consulting Group
Chemistry · 512d
Cleared Dec 22, 1998
LIGHT DIAGNOSTICS RABIES DFA REAGENT
K972975 · GOI
Light Diagnostics
Microbiology · 498d
Cleared Dec 22, 1998
SUMMIT KRUMEICH-BARRAQUER MICROKERATOME
K980675 · HNO
Summit Technology, Inc.
Ophthalmic · 305d