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
125449–125472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 1990
ENEMA BAG SET
K901182 · FCE
Orion Life Systems, Inc.
Gastroenterology & Urology · 107d
Cleared Jun 28, 1990
LAMINECTOMY RONGEUR
K901372 · HAE
Zeppelin GmbH
Neurology · 98d
Cleared Jun 28, 1990
ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM
K901503 · ESE
Stanton Magnetics, Inc.
Ear, Nose, Throat · 90d
Cleared Jun 28, 1990
MOUTHPIECE BREATHING
K901563 · JXL
Scott All-Sports, Inc.
Neurology · 86d
Cleared Jun 28, 1990
LATEX EXAMINATION GLOVES
K901579 · LYY
P.T. Perkebunan
General Hospital · 85d
Cleared Jun 28, 1990
BIO-MEDICUS BIO CONSOLE MODELS 540 A B C
K901584 · DWA
Bio Medicus, Inc.
Cardiovascular · 85d
Cleared Jun 28, 1990
ELECTROGLOTTOGRAPH
K901609 · KLX
Glottal Ent., Inc.
Ear, Nose, Throat · 83d
Cleared Jun 28, 1990
RUBELLA IGG ELISA TEST
K901635 · LFX
Gull Laboratories, Inc.
Microbiology · 80d
Cleared Jun 28, 1990
MODIFIED IVT PERIPHERAL ATHERECTOMY
K901767 · LIT
Intensive Technology, Inc.
Cardiovascular · 72d
Cleared Jun 28, 1990
LATEX PATIENT EXAMINATION GLOVES
K901801 · LYY
Fujian Provincial Medicines and...
General Hospital · 70d
Cleared Jun 28, 1990
INTRASITE CAVITY WOUND DRESSING (LABEL REVISION)
K901876 · KOZ
Smith & Nephew United, Inc.
General & Plastic Surgery · 63d
Cleared Jun 28, 1990
HELIO PROGRESS (DENTAL COMPOSITE)
K901914 · EBF
Ivoclar North America, Inc.
Dental · 63d
Cleared Jun 28, 1990
DUAL CEMENT
K901917 · EBF
Ivoclar North America, Inc.
Dental · 63d
Cleared Jun 28, 1990
COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2
K901933 · JFH
Diagnostic Products Corp.
Chemistry · 59d
Cleared Jun 28, 1990
MOBILE MRP-20 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K901980 · LNH
Summit World Trade Corp.
Radiology · 57d
Cleared Jun 28, 1990
KODAK SURECELL(TM) HCG-URINE TEST KIT
K902136 · JHI
Eastman Kodak Company
Chemistry · 49d
Cleared Jun 28, 1990
COULTER CREATININE REAGENT
K902172 · CGX
Coulter Corp.
Chemistry · 45d
Cleared Jun 28, 1990
HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235)
K902321 · JJT
Hichem Diagnostics
Chemistry · 36d
Cleared Jun 28, 1990
SYNERMED TOTAL BILIRUBIN REAGENT KIT
K902328 · CIG
Synermed, Inc.
Chemistry · 35d
Cleared Jun 28, 1990
SILVER-FREE CERAMIC SOLDER (SFCS)
K902372 · EJT
Leach and Dillon Co., Inc.
Dental · 30d
Cleared Jun 28, 1990
200 SILHOUETTE LINE (SL) CERAMIC SOLDER
K902373 · EJT
Leach and Dillon Co., Inc.
Dental · 30d
Cleared Jun 28, 1990
DW231 DENTAL ALLOY
K902376 · EJS
Ivoclar North America, Inc.
Dental · 30d
Cleared Jun 28, 1990
DEGUSSA STOPFGOLD (DEGUSSA DIRECT-FILLING GOLD)
K902387 · EJT
Degussa AG
Dental · 29d
Cleared Jun 28, 1990
DENTAL-QUECKSILBER (DENTAL MERCURY)
K902388 · ELY
Degussa AG
Dental · 29d