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
117433–117456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1992
DURA II PENILE PROSTHESIS
K920420 · FAE
Dacomed Corp.
Gastroenterology & Urology · 76d
Cleared Apr 16, 1992
GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB
K920516 · KDD
Trinity Laboratories, Inc.
General & Plastic Surgery · 72d
Cleared Apr 16, 1992
COLLIMATOR F-20
K920725 · IZW
Shimadzu Medical Systems
Radiology · 58d
Cleared Apr 16, 1992
CEILING TUBE SUPPORT CH-30X
K920727 · IYB
Shimadzu Medical Systems
Radiology · 58d
Cleared Apr 16, 1992
CATHERIZATION KS-50
K920732 · IZZ
Shimadzu Medical Systems
Radiology · 58d
Cleared Apr 16, 1992
STEREO COLLIMATOR RF-T SERIES
K920733 · IZW
Shimadzu Medical Systems
Radiology · 58d
Cleared Apr 16, 1992
BARD URETEROSCOPE DEFLECTION MODULE
K920750 · FGB
C.R. Bard, Inc.
Gastroenterology & Urology · 57d
Cleared Apr 15, 1992
ORION
K910152 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 457d
Cleared Apr 15, 1992
OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USE
K912611 · GEI
Olsen Electrosurgical, Inc.
General & Plastic Surgery · 308d
Cleared Apr 15, 1992
A-V IMPULSE SYSTEM
K914461 · JOW
Novamedix , Ltd.
Cardiovascular · 191d
Cleared Apr 15, 1992
THERMO-FLOW SET
K914686 · BTT
Inhalation Plastics
Anesthesiology · 180d
Cleared Apr 15, 1992
GLEESON CLOT-BUSTER
K920139 · GCI
Conmedcorp
General & Plastic Surgery · 93d
Cleared Apr 15, 1992
OPTICAL FRAME A285, A210, B220, A215, A255, B220,
K920181 · HQZ
Kentucky Optical Co.
Ophthalmic · 91d
Cleared Apr 15, 1992
CEPTI-SEAL DRESSING CHNG. KIT FOR CENT. VENOUS CAT
K920398 · FMF
Medi-Flex Hospital Products, Inc.
General Hospital · 76d
Cleared Apr 15, 1992
RMI SOFCLAMP
K920676 · DSS
Research Medical, Inc.
Cardiovascular · 61d
Cleared Apr 15, 1992
DIGITAL RADIOGRAPHY SYSTEM IDR-2000
K920721 · JAA
Shimadzu Medical Systems
Radiology · 57d
Cleared Apr 14, 1992
ASEP SURGEONS GOWN
K914235 · FYA
Baxter Interwoven Offsite
General Hospital · 207d
Cleared Apr 14, 1992
FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT
K915110 · KNT
Abbott Laboratories
Gastroenterology & Urology · 153d
Cleared Apr 14, 1992
PACEART CPTS-86/12
K915632 · KRE
Paceart, Inc.
Cardiovascular · 119d
Cleared Apr 14, 1992
ULTRA+ BLOOD GLUCOSE TEST STRIP
K915770 · CGA
Home Diagnostics, Inc.
Chemistry · 112d
Cleared Apr 14, 1992
DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP
K915772 · CGA
Home Diagnostics, Inc.
Chemistry · 112d
Cleared Apr 14, 1992
PATIENT EXAMINATION GLOVE
K915842 · LYY
Precious Mountain Ent. Corp.
General Hospital · 110d
Cleared Apr 14, 1992
INSTRUMENTARIUM MEGA4 HT
K920215 · LNH
Instrumentarium Imaging, Inc.
Radiology · 89d
Cleared Apr 14, 1992
CIRCLEXO.3T X-RAY TUBE ASSEMBLY
K920387 · ITY
Shimadzu Medical Systems
Radiology · 75d