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
107185–107208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1994
GENEMED YAG 1000 MEDICAL LASER
K943479 · GEX
Genemed, Inc.
General & Plastic Surgery · 72d
Cleared Sep 29, 1994
TECHNA-CUT ASPIRATION NEEDLE
K943651 · KNW
Manan Medical Products, Inc.
Gastroenterology & Urology · 63d
Cleared Sep 29, 1994
ROYAL SHIELD PINK COLORED NON-STERILE LATEX EXAMINATION GLOVE
K943807 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 56d
Cleared Sep 29, 1994
EURO TECH STERLING ROLLER TABLE
K943973 · JFB
Progressive Electrical Therapeutics
Physical Medicine · 45d
Cleared Sep 29, 1994
EURO TECH MARQUISE CHIROPRACTIC TABLE
K943974 · INW
Progressive Electrical Therapeutics
Physical Medicine · 45d
Cleared Sep 29, 1994
EURO TECH PLATINUM CHIROPRACTIC TABLE
K943975 · INW
Progressive Electrical Therapeutics
Physical Medicine · 45d
Cleared Sep 29, 1994
SURGI-LINK DISPOSABLE PUSH BUTTON ESU PENCIL
K944617 · GEI
Unimed Surgical Products, Inc.
General & Plastic Surgery · 9d
Cleared Sep 28, 1994
ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW
K926417 · KTT
Alphatec Mfg., Inc.
Orthopedic · 644d
Cleared Sep 28, 1994
MIC TRANSGASTRIC JEJUNAL TUBE
K926581 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 727d
Cleared Sep 28, 1994
MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH
K930623 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 597d
Cleared Sep 28, 1994
ZEISS OPMI L STEREO-LAPAROSCOPE
K931478 · HET
Carl Zeiss, Inc.
Obstetrics & Gynecology · 553d
Cleared Sep 28, 1994
SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE
K931963 · FFT
Sandhill Scientific, Inc.
Gastroenterology & Urology · 525d
Cleared Sep 28, 1994
LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI
K933014 · KFM
St. Jude Medical, Inc.
Cardiovascular · 464d
Cleared Sep 28, 1994
P.F.C. CERAMIC HIP HEAD
K933275 · LZO
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 449d
Cleared Sep 28, 1994
GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS
K935198 · KNT
Lake Region Mfg., Inc.
Gastroenterology & Urology · 336d
Cleared Sep 28, 1994
AUTOMATIC LENSOMETER
K936199 · HLM
Canon USA, Inc.
Ophthalmic · 273d
Cleared Sep 28, 1994
WIRELESS CHART PROJECTOR,HCP-W 721
K936200 · HOS
Canon USA, Inc.
Ophthalmic · 273d
Cleared Sep 28, 1994
COMPREHENSIVE PHOROPTER, MDR-680
K936205 · HKN
Canon USA, Inc.
Ophthalmic · 273d
Cleared Sep 28, 1994
STANDARD PHACO TIP 15, 30, 45, 60
K940083 · HQC
Medical Technical Products
Ophthalmic · 264d
Cleared Sep 28, 1994
KARL STORZ ENDOVISION UROCAM/HYSTEROCAM
K940283 · FET
Medical Concepts, Inc.
Gastroenterology & Urology · 252d
Cleared Sep 28, 1994
ACUFEX ACL SHEATH FOR INTERFERENCE SCREWS
K940290 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 250d
Cleared Sep 28, 1994
SHIPPERT PRESSURE BANDAGE
K940798 · KGX
Denver Splint Co.
General & Plastic Surgery · 218d
Cleared Sep 28, 1994
SUNGLASSES
K941006 · HQY
Opti-Ray, Inc.
Ophthalmic · 205d
Cleared Sep 28, 1994
CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES
K941036 · HRX
Smith & Nephew, Inc.
Orthopedic · 205d