Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
169441–169464 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 1979
INSTANT HOT & COLD PACKS
K790993 · IMD
Chase Mfg. Co.
Physical Medicine · 101d
Cleared Sep 07, 1979
ANTIBODY TO HERPESVIRUS HOMINIS
K791058 · GQO
Electro-Nucleonics Laboratories, Inc.
Microbiology · 91d
Cleared Sep 07, 1979
CONPHAR FEMALE CATHETER-STERILE
K791244 · KOD
Conphar, Inc.
Gastroenterology & Urology · 63d
Cleared Sep 07, 1979
CONPHAR FEMALE CATHETER W/BAG-STERILE
K791252 · KNX
Conphar, Inc.
Gastroenterology & Urology · 63d
Cleared Sep 07, 1979
CONPHAR URINARY DRAINAGE BAG-2000ML
K791265 · KNX
Conphar, Inc.
Gastroenterology & Urology · 63d
Cleared Sep 07, 1979
TECHNION ELECTRONIC FEVER THERMOMETER
K791323 · FLL
Technicon Corp.
General Hospital · 52d
Cleared Sep 07, 1979
SYSTEC 280 INTEGRATED SUCTION SYSTEM
K791349 · BTA
Stryker Corp.
General & Plastic Surgery · 53d
Cleared Sep 07, 1979
THE MTD VARA SET CASETTE HOLDER
K791374 · KPR
Mtd, Inc.
Radiology · 45d
Cleared Sep 07, 1979
CATHETERIZATION TRAYS FOLEY AND URETHRAL
K791427 · KOD
Intermed, Inc.
Gastroenterology & Urology · 43d
Cleared Sep 07, 1979
VACUTOME SUCTION UNIT
K791494
Concept, Inc.
General & Plastic Surgery · 36d
Cleared Sep 07, 1979
AUTOMATIC POSITIVE BEAM COLLIMATOR
K791504 · KPW
Dial-X Instruments, Inc.
Radiology · 32d
Cleared Sep 07, 1979
DISPOSABLE MEDICATION NEBULIZER
K791536 · CAF
Hospitak, Inc.
Anesthesiology · 28d
Cleared Sep 07, 1979
DISPOSABLE MOUTHPIECE
K791537 · BYP
Hospitak, Inc.
Anesthesiology · 28d
Cleared Sep 07, 1979
DISPOSABLE AEROSOL T
K791538 · BZA
Hospitak, Inc.
Anesthesiology · 28d
Cleared Sep 07, 1979
DISPOSABLE 22MM ADAPTOR
K791539 · BZA
Hospitak, Inc.
Anesthesiology · 28d
Cleared Sep 07, 1979
GILLETTE CORDLESS WHIRLPOOL
K791603 · ILJ
The Gillette Company
Physical Medicine · 24d
Cleared Sep 07, 1979
REUSABLE MOIST HEAT PACK
K791653 · IMA
Tru-Eze Mfg. Co., Inc.
Physical Medicine · 24d
Cleared Sep 07, 1979
MEDTRONIC MODELS 69914/699OU
K791667 · DTB
Medtronic Vascular
Cardiovascular · 10d
Cleared Sep 07, 1979
LITHICRON II 0403 IMPLANTABLE PACEMAKER
K791678 · DXY
Medcor, Inc.
Cardiovascular · 10d
Cleared Sep 04, 1979
ANTISERUM, HUMAN, IGG H & L CHAIN
K790702 · DEW
Kent Laboratories, Inc.
Immunology · 145d
Cleared Sep 04, 1979
ANTISERA TO HUMAN FRAGMENT
K790711 · DFK
Kent Laboratories, Inc.
Immunology · 145d
Cleared Sep 04, 1979
ANTISERUM TO HUMAN HEMOPEXIN
K790713 · CZX
Kent Laboratories, Inc.
Immunology · 145d
Cleared Sep 04, 1979
RP-610 PARALLEL PLATE DIALYZER
K790827 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 137d
Cleared Sep 04, 1979
TONGUE SCRAPER
K790895 · LCN
Peter G. Finamore, Sr.
Dental · 120d