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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
172993–173016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 15, 1977
AV FISTULA NEEDLE SET
K771206 · FIE
Terumo America, Inc.
Gastroenterology & Urology · 10d
Cleared Jul 15, 1977
SUPERFINE DIAMONDS
K771214 · EJL
Den-Mat Corp.
Dental · 10d
Cleared Jul 15, 1977
PHENYTOIN ANALYTICAL TEST PACKS
K771233 · DIP
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 8d
Cleared Jul 15, 1977
RID PLATES & INTENSI. FOR HUMAN IGE ETC
K771238 · DGC
G.D. Searle and Co.
Immunology · 4d
Cleared Jul 15, 1977
ALARM SYS FOR NITROUS OXIDE SYS.
K771246 · ECX
Star Dental Mfg. Co.
Anesthesiology · 4d
Cleared Jul 15, 1977
CORE MATERIAL
K771247 · EBF
Star Dental Mfg. Co.
Dental · 4d