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
157321–157344 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 1983
PREFILLED IEC COLUMNS
K831289 · DJY
Berwick Medical Products, Inc.
Toxicology · 57d
Cleared Jun 16, 1983
HEMACAL
K831306 · KRZ
Hematology Marketing Assoc.
Hematology · 55d
Cleared Jun 16, 1983
VASCULAB BLOOD PRESSURE CUFF
K831393 · DXQ
Medasonics, Inc.
Cardiovascular · 48d
Cleared Jun 16, 1983
COLORIMETRIC BUN
K831414 · CDL
Bio-Analytics Laboratories, Inc.
Chemistry · 45d
Cleared Jun 16, 1983
LACTIC DEHYDROGENASE REAGENT SET
K831415 · CFJ
Sterling Biochemical, Inc.
Chemistry · 45d
Cleared Jun 16, 1983
EMIT QST TOBRAMYCIN CONTROL
K831417 · LAS
Syva Co.
Toxicology · 44d
Cleared Jun 16, 1983
RAICHEM LDH-P REAGENT W/SEPARATE START-
K831419 · CFJ
Reagents Applications, Inc.
Chemistry · 44d
Cleared Jun 16, 1983
ASO-CHECK
K831464 · GTQ
Diagnostic Technology, Inc.
Immunology · 41d
Cleared Jun 16, 1983
LEG DRAINAGE BAG STRAP BK6011
K831553 · KNX
Fred Sammons, Inc.
Gastroenterology & Urology · 35d
Cleared Jun 16, 1983
E-Z PREP
K831558 · GKJ
Coulter Electronics, Inc.
Hematology · 31d
Cleared Jun 16, 1983
ALBUMIN REAGENT (BCG
K831585 · CIX
Reagents Applications, Inc.
Immunology · 30d
Cleared Jun 16, 1983
VENT TUBE FORCEPS
K831589 · EQH
Treace Medical, Inc.
Ear, Nose, Throat · 30d
Cleared Jun 16, 1983
ANHYDRIC INCUBATORS, CULTURE INCUBATOR
K831592 · JTQ
Boekel Industries, Inc.
Pathology · 30d
Cleared Jun 16, 1983
DILUENT
K831617 · GIF
Omega Medical Diagnostics
Hematology · 28d
Cleared Jun 16, 1983
HEMOGLOBIN REAGENT
K831618 · GKR
Omega Medical Diagnostics
Hematology · 28d
Cleared Jun 16, 1983
PRIVATE LABEL DEODORANT MINISHIELDS
K831692
Int'L Consumer Disposables
Obstetrics & Gynecology · 23d
Cleared Jun 16, 1983
MAXI PADS SCENTED DEODORIZED
K831693 · HHL
Int'L Consumer Disposables
Obstetrics & Gynecology · 35d
Cleared Jun 16, 1983
MODIFIED UNSCENTED MENSTRUAL PADS
K831707 · HHD
Personal Products Co.
Obstetrics & Gynecology · 21d
Cleared Jun 15, 1983
APPOSE SKIN STAPLER & REMOVER
K823552 · GDW
American Cyanamid Co.
General & Plastic Surgery · 197d
Cleared Jun 15, 1983
CENTRAL STATION DISPLAY/RECORDER MATRIX
K830517 · DRT
Marquette Electronics, Inc.
Cardiovascular · 118d
Cleared Jun 15, 1983
QUIK-SILVER RESTING ECG ELECTRODE
K830655 · DRX
Quinton, Inc.
Cardiovascular · 105d
Cleared Jun 15, 1983
WHITE BLOOD CELL CONTROL
K830864 · JPK
Control Diagnostics
Chemistry · 89d
Cleared Jun 15, 1983
THERMODILUTION CARDIAC OUTPUT COMPUTER-
K830892 · DXG
American Edwards Laboratories
Cardiovascular · 86d
Cleared Jun 15, 1983
PULSAMAT MODEL 1050
K830906 · FRN
Ferring Laboratories, Inc.
General Hospital · 86d