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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
112345–112368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 1993
CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE)
K930987 · KTL
The Binding Site, Ltd.
Immunology · 166d
Cleared Aug 10, 1993
PYRAMID SUNGLASSES/PYRAMID READING GLASSES
K931328 · HOI
Pyramid
Ophthalmic · 147d
Cleared Aug 10, 1993
BIVONA(R) ICU ENDOTRACHEAL TUBE
K931749 · BTR
Bivona Medical Technologies
Anesthesiology · 124d
Cleared Aug 10, 1993
ENDOSCOPIC BLUNT DISSECTING INSTRUMENT
K931854 · FGS
Mayaguez Medical Center
Gastroenterology & Urology · 119d
Cleared Aug 10, 1993
5.0 MM IRRIGATION/ASPIRATION PROBE
K931856 · GCY
Mayaguez Medical Center
General & Plastic Surgery · 119d
Cleared Aug 10, 1993
IRRIGATING BLUNT DISSECTOR
K931912 · KYZ
Mayaguez Medical Center
General Hospital · 116d
Cleared Aug 10, 1993
OUT FOR FUN! HAPPY MEAL MCDONALDLAND SUNGLASSES
K932018 · HQY
Simon Marketing, Inc.
Ophthalmic · 109d
Cleared Aug 10, 1993
MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER
K932228 · GBZ
Boston Scientific Corp
General & Plastic Surgery · 95d
Cleared Aug 10, 1993
ANA PROFILE I
K932424 · LJM
Apotex Scientific, Inc.
Immunology · 83d
Cleared Aug 10, 1993
UNIGRIP-FH SURGICAL HANDPIECE/LAPAROSCOPIC
K932604 · GCJ
Unisurge, Inc.
General & Plastic Surgery · 74d
Cleared Aug 10, 1993
REMEL CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK
K933118 · JTN
Remel Co.
Microbiology · 46d
Cleared Aug 10, 1993
DEVMED LAP WASH REUSABLE ENDOSCOPIC LENS WASH SHEATH
K933416 · GCJ
Devmed Corp.
General & Plastic Surgery · 29d
Cleared Aug 09, 1993
CASTLE WASHER/DISINFECTOR, MODEL 7550
K911087
Mdt Biologic Co.
General & Plastic Surgery · 882d
Cleared Aug 09, 1993
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA
K923903 · LJY
Biomerieux Vitek, Inc.
Microbiology · 370d
Cleared Aug 09, 1993
SENSORMEDICS MODEL 6200 AUTOBOX DL
K923989 · BZG
Sensor Medics Corp.
Anesthesiology · 363d
Cleared Aug 09, 1993
STACLOT(R) PNP TEST KIT
K924370 · GGW
American Bioproducts Co.
Hematology · 346d
Cleared Aug 09, 1993
CORIN BIPOLAR PROSTHESIS
K925897 · KWY
Corin Orthopedic Products
Orthopedic · 263d
Cleared Aug 09, 1993
WELLS LAMONT HANDAGES/MED WRAP DRESSINGS
K925937 · KMF
Wells Lamont Corp.
General & Plastic Surgery · 258d
Cleared Aug 09, 1993
MARCO STANDARD RADIUSGAUGES
K930437 · HLF
Marco Ophthalmic, Inc.
Ophthalmic · 195d
Cleared Aug 09, 1993
MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS
K930438 · HJO
Marco Ophthalmic, Inc.
Ophthalmic · 195d
Cleared Aug 09, 1993
MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS
K930442 · HKI
Marco Ophthalmic, Inc.
Ophthalmic · 195d
Cleared Aug 09, 1993
MARCO STANDARD KERATOMETERS
K930444 · HJB
Marco Ophthalmic, Inc.
Ophthalmic · 195d
Cleared Aug 09, 1993
DU PONT ACA NEV/EEV VERIFIER
K930501 · JIS
Dupont Medical Products
Chemistry · 189d
Cleared Aug 09, 1993
M6-M
K930699 · IZL
X-Cel X-Ray Corp.
Radiology · 180d