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
127945–127968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 1989
500 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS
K895062 · EJT
Leach and Dillon Co., Inc.
Dental · 132d
Cleared Dec 18, 1989
MONOGRAM II
K895064 · EJT
Leach and Dillon Co., Inc.
Dental · 132d
Cleared Dec 18, 1989
MONOGRAM III
K895065 · EJT
Leach and Dillon Co., Inc.
Dental · 132d
Cleared Dec 18, 1989
SELECT 50
K895068 · EJT
Leach and Dillon Co., Inc.
Dental · 132d
Cleared Dec 18, 1989
DIATECH IGM-MP TEST
K895276 · LJZ
Diatech Diagnostica , Ltd.
Microbiology · 117d
Cleared Dec 18, 1989
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
K895647 · HGL
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 89d
Cleared Dec 18, 1989
EBV-EA IFA KIT
K895652 · LSE
Organon Teknika Treyburn
Microbiology · 89d
Cleared Dec 18, 1989
LYNX-HIGH SPEED HANDPIECE
K895736 · EFB
Mti Precision Products
Dental · 83d
Cleared Dec 18, 1989
LITELINE VLC SOFT RELINE
K895742 · EBI
Dentsply Intl.
Dental · 83d
Cleared Dec 18, 1989
STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC'
K895807 · LYY
Safeskin Corp.
General Hospital · 80d
Cleared Dec 18, 1989
TWO MIRROR GONIO LENS
K895846 · HKS
Ocular Instruments, Inc.
Ophthalmic · 76d
Cleared Dec 18, 1989
METAL URETERAL BASKET STONE DISLODGER
K896169 · FFL
Annex Medical, Inc.
Gastroenterology & Urology · 54d
Cleared Dec 18, 1989
MAINSTER WIDE FIELD LASER LENS
K896198 · HJK
Ocular Instruments, Inc.
Ophthalmic · 52d
Cleared Dec 18, 1989
JEDMED J-II CHAIR
K896275 · FRK
Jedmed Instrument Co.
General Hospital · 49d
Cleared Dec 18, 1989
MULTI-USE I/A HANDPIECE
K896305 · HQE
Advanced Surgical Products, Inc.
Ophthalmic · 49d
Cleared Dec 18, 1989
TITAN AIR SPECTACLE FRAME
K896350 · HQJ
Acces Intl. Eyewear
Ophthalmic · 42d
Cleared Dec 18, 1989
DIFCO OXIDASE DRYSLIDE
K896398 · JTO
Difco Laboratories, Inc.
Microbiology · 42d
Cleared Dec 18, 1989
VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY
K896852 · DHB
Ventrex Laboratories, Inc.
Immunology · 13d
Cleared Dec 15, 1989
CATHETER CARE KITS
K894611 · FOZ
L H M Ent., Inc.
General Hospital · 148d
Cleared Dec 15, 1989
PERCUTANEOUS INTRAVENOUS CATHETERS
K895712 · LJS
Pharmacia Deltec, Inc.
General Hospital · 81d
Cleared Dec 14, 1989
QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM
K892711 · LLZ
Quantitative Cardiac Systems (Qcs), Inc.
Radiology · 244d
Cleared Dec 14, 1989
SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTY
K893136 · HRX
Dyonics, Inc.
Orthopedic · 233d
Cleared Dec 14, 1989
ACCUMED LATEX SURGICAL GLOVE
K893834 · KGO
Accurate Medical Devices, Inc.
General Hospital · 204d
Cleared Dec 14, 1989
IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT
K893994 · IPF
Rich-Mar Corp.
Physical Medicine · 192d