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
156481–156504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 15, 1983
REFERENCE BUFFER PH 7.382
K831023 · CHL
Fisher Scientific Co., LLC
Chemistry · 77d
Cleared Jun 15, 1983
STROMA II
K831096 · EJS
Unitek Corp.
Dental · 72d
Cleared Jun 15, 1983
CONCERTO
K831097 · EJS
Unitek Corp.
Dental · 72d
Cleared Jun 15, 1983
COMMAND ULTRA I
K831161 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 65d
Cleared Jun 15, 1983
DELIVERY 4 TABLE
K831309 · KNC
Amsco Co.
Obstetrics & Gynecology · 54d
Cleared Jun 15, 1983
PMT VAXIOM STEREOTACTIC SYS #FX001
K831329 · HAW
Progress Mankind Technology
Neurology · 51d