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
125857–125880 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 1990
CHEM-CHEX BILIRUBIN
K902867 · JJX
Streck Laboratories, Inc.
Chemistry · 17d
Cleared Jul 16, 1990
UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE
K902897 · LRM
United Biotech, Inc.
Immunology · 13d
Cleared Jul 13, 1990
SIEMENS SONOLINE AC
K896480 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 240d
Cleared Jul 13, 1990
UNSCENTED MENSTRUAL TAMPON
K897007 · HEB
Personal Products Co.
Obstetrics & Gynecology · 207d
Cleared Jul 13, 1990
THIN CONDOM RAMSES & SHEIK
K897140 · HIS
Schmid Laboratories, Inc.
Obstetrics & Gynecology · 198d
Cleared Jul 13, 1990
BSI MODEL TIP
K897191 · LHQ
Bales Scientific, Inc.
Radiology · 197d
Cleared Jul 13, 1990
TEMPORARY CROWN MATRIX BUTTONS
K900389 · EBG
Advantage Dental Products, Inc.
Dental · 165d
Cleared Jul 13, 1990
LIFE-TEL CELLULAR TRANSCEIVER
K900541 · DXH
Racom, Inc.
Cardiovascular · 158d
Cleared Jul 13, 1990
MODEL 9200 RESPIRATION/HEART RATE MONITOR
K901656 · BZQ
Aequitron Medical, Inc.
Anesthesiology · 94d
Cleared Jul 13, 1990
MDL-2000 LASERTRIPTER
K901723 · LNK
Candela Laser Corp.
Gastroenterology & Urology · 88d
Cleared Jul 13, 1990
HELIOLUX VISIBLE CURING LIGHT
K901908 · EBZ
Ivoclar North America, Inc.
Dental · 78d
Cleared Jul 13, 1990
DENDIA WERK BURS AND CUTTING DISCS
K901967 · DZP
Micro-Aire Surgical Instruments, Inc.
Dental · 73d
Cleared Jul 13, 1990
SEAL RITE PROCEDURE KIT(TM)
K902023 · EBC
Pulpdent Corp.
Dental · 70d
Cleared Jul 13, 1990
AHYDRON DENTAL CLEANING AGENT
K902052 · EMA
Ivoclar North America, Inc.
Dental · 67d
Cleared Jul 13, 1990
SARNS DELPHIN BASE ADAPTER WITH BATTERY
K902198 · KFM
3M Company
Cardiovascular · 58d
Cleared Jul 13, 1990
ARTALLOY (POWDER)
K902247 · EJJ
Degussa AG
Dental · 56d
Cleared Jul 13, 1990
LUXALLOY CAPS (PREDOSED CAPSULES)
K902248 · EJJ
Degussa AG
Dental · 56d
Cleared Jul 13, 1990
LUXALLOY 50 (POWDER, TABLETS, PREDOSED CAPSULES)
K902249 · EJJ
Degussa AG
Dental · 56d
Cleared Jul 13, 1990
EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL
K902531 · EGW
G-C Intl. Corp.
Radiology · 38d
Cleared Jul 13, 1990
GSI 17 SCREENING AUDIOMETER
K902540 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 37d
Cleared Jul 13, 1990
CARDIOMATIC MODEL MSC-1001
K902608 · DRT
Medical Systems Corp.
Cardiovascular · 31d
Cleared Jul 13, 1990
GYNESCOPE LAPAROSCOPES
K902655 · HET
Gynescope Corp.
Obstetrics & Gynecology · 28d
Cleared Jul 13, 1990
MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON
K902785 · BZQ
Aequitron Medical, Inc.
Anesthesiology · 17d
Cleared Jul 12, 1990
ABBOTT PATIENT CONTROLLED ANALGESIA (PCA) PUMP
K895709 · FRN
Abbott Laboratories
General Hospital · 290d