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
173833–173856 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1977
PACEMAKER & CARDIAC LEAD, BIPOLAR
K771262 · DXY
Arco Medical Products Co.
Cardiovascular · 10d
Cleared Jul 21, 1977
QUADRIPLEGIC MEAT KNIFE
K771274 · ILC
Fred Sammons, Inc.
Physical Medicine · 38d
Cleared Jul 21, 1977
FINGEO EXTENSION SPLINTS
K771287 · IQM
Fred Sammons, Inc.
Physical Medicine · 38d
Cleared Jul 21, 1977
JAMAR DYNAMOMETEO BK-7498
K771288 · HRW
Fred Sammons, Inc.
Neurology · 38d
Cleared Jul 19, 1977
CATHETERS, DRAINAGE
K771048 · FEG
Axiom Medical, Inc.
Gastroenterology & Urology · 39d
Cleared Jul 15, 1977
NF DEVICE
K770517 · KPD
Rpr, Inc.
General Hospital · 119d
Cleared Jul 15, 1977
FLAME PHOTOMETER MOLEL 4600, KDA
K770824 · JIH
American Monitor Corp.
Chemistry · 72d
Cleared Jul 15, 1977
TRAY, BLOOD GAS, ARTERIAL, #4014
K770850 · FMF
Concord Laboratories, Inc.
General Hospital · 67d
Cleared Jul 15, 1977
LIPOPROTEIN PROFILING SYSTEM
K770948 · JHL
Beckman Instruments, Inc.
Chemistry · 51d
Cleared Jul 15, 1977
CARDIOZYME CK-TOTAL REAGENTS
K770972
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 45d
Cleared Jul 15, 1977
UNITED SKIN BARRIER
K770982 · EXE
Howmedica Corp.
Gastroenterology & Urology · 45d
Cleared Jul 15, 1977
TRENDAR
K771000 · CGA
Hi Chem, Inc.
Chemistry · 42d
Cleared Jul 15, 1977
CHOLINESTERASE REAGENT SYSTEM
K771024 · DLI
American Monitor Corp.
Chemistry · 37d
Cleared Jul 15, 1977
TMA BICARBONATE DILUENT
K771044 · JJS
Hyland Therapeutic Div., Travenol...
Chemistry · 35d
Cleared Jul 15, 1977
HERITAGE SPECIAL ALLOY
K771110 · EJT
Howmedica Corp.
Dental · 25d
Cleared Jul 15, 1977
PASTES, RESTORATIVE & TINTED, DEBTAL
K771119 · EBF
Espe Dental Products
Dental · 23d
Cleared Jul 15, 1977
NEKO CERAMIC CONVENIENCE CROWNS
K771128 · ELZ
Sterndent Corp.
Dental · 22d
Cleared Jul 15, 1977
DESENSITRON
K771130 · EGJ
Parker Laboratories, Inc.
Physical Medicine · 22d
Cleared Jul 15, 1977
WILL-CERAM W-2
K771145 · EJS
Williams Gold Refining Co., Inc.
Dental · 18d
Cleared Jul 15, 1977
BIOBOND MASTER STAIN AND GLAZE KIT
K771179 · ELL
Dentsply Intl.
Dental · 15d
Cleared Jul 15, 1977
TOOTHBRUSH, PEDODONTIC, #0126-0188-00
K771183 · EFW
Hoyt Laboratories
Dental · 16d
Cleared Jul 15, 1977
TOOTHBRUSH, ORTHODONTIC, #0126-0189-00
K771184 · EFW
Hoyt Laboratories
Dental · 16d
Cleared Jul 15, 1977
PERIODONTIC TOOTHBRUSH, #0126-0190-00
K771185 · EFW
Hoyt Laboratories
Dental · 16d
Cleared Jul 15, 1977
MICRO BI-POLAR FORCEPS #39-200
K771186 · HAM
Edward Weck, Inc.
General & Plastic Surgery · 14d