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
128545–128568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 14, 1989
CONDOM (RUBBER LATEX) OKEIDO
K894534 · HIS
Rfsu
Obstetrics & Gynecology · 148d
Cleared Dec 14, 1989
RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT
K894643 · IZL
Lorad Medical Systems, Inc.
Radiology · 143d
Cleared Dec 14, 1989
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TF
K894887 · JAK
Shimadzu Medical Systems
Radiology · 135d
Cleared Dec 14, 1989
BIRDS'N BEES CONDOMS
K895028 · HIS
Rfsu
Obstetrics & Gynecology · 128d
Cleared Dec 14, 1989
KIM MODULAR FEMORAL HIP PROSTHESIS
K895399 · LZO
Dow Corning Wright
Orthopedic · 98d
Cleared Dec 14, 1989
OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM)
K895408 · KGX
Smith & Nephew United, Inc.
General & Plastic Surgery · 99d
Cleared Dec 14, 1989
THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL
K895442 · KPQ
Altek Corp.
Radiology · 97d
Cleared Dec 14, 1989
CIVCO LATEX ULTRASOUND SHEATHS
K895614 · IYO
CIVCO Medical Instruments Co., Inc.
Radiology · 86d
Cleared Dec 14, 1989
DIMENSION REVISION TOTAL HIP SYSTEM
K895636 · JDI
Kirschner Medical Corp.
Orthopedic · 86d
Cleared Dec 14, 1989
MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR
K895837 · GEX
Medical Laser, Inc.
General & Plastic Surgery · 72d