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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
114865–114888 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 1993
ANGIOGRAPHIC BALLOON CATHETER BY J LLOYD
K920870 · DQO
J-Lloyd Medical, Inc.
Cardiovascular · 317d
Cleared Jan 07, 1993
MS-100 MYO-SCANNER OR MS-100 EMG SCANNER
K921919 · KZM
Myo-Tronics, Inc.
Dental · 259d
Cleared Jan 07, 1993
LSF ANATOMIC CEMENTED HIP
K922645 · JDI
Osteo Technology, Inc.
Orthopedic · 218d
Cleared Jan 07, 1993
BIVONA HYPERFLEX TRACHEOSTOMY TUBE
K922665 · JOH
Bivona Medical Technologies
Anesthesiology · 220d
Cleared Jan 07, 1993
ES1700 ECG MODULATOR
K922783 · DXH
Epic Systems, Inc.
Cardiovascular · 212d
Cleared Jan 07, 1993
OH-500 OXYGEN CONCENTRATOR
K924146 · CAW
Healthdyne, Inc.
Anesthesiology · 142d
Cleared Jan 07, 1993
MSI-HCT
K924926 · GLK
Medical Specialties, Inc.
Hematology · 99d
Cleared Jan 07, 1993
AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38
K925254 · HQC
Allergan Medical Optics
Ophthalmic · 80d
Cleared Jan 06, 1993
MECONIUM SUCTION DEVICE (MSD)
K914370 · BTR
Vital Signs, Inc.
Anesthesiology · 463d
Cleared Jan 06, 1993
SHAWNEE PRODUCTS KIT I
K921762 · LRR
Absentee Shawnee Bandage Group
General & Plastic Surgery · 267d
Cleared Jan 06, 1993
UPSHERSCOPE(TM)
K922275 · CCW
Upsher Laryngoscope Co.
Anesthesiology · 237d
Cleared Jan 06, 1993
ENVIROMATE(TM) SMOKE EVACUATION SYSTEM
K922555 · FYD
Lase, Inc.
General Hospital · 222d
Cleared Jan 06, 1993
ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION
K922787 · DQX
Echocath, Inc.
Cardiovascular · 211d
Cleared Jan 06, 1993
RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY
K922801 · GNY
Light Diagnostics
Microbiology · 210d
Cleared Jan 06, 1993
COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600
K923367 · KRH
Baxter Healthcare Corp
Cardiovascular · 181d
Cleared Jan 06, 1993
TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686)
K924194 · BTO
American Healthcare Corp.
Anesthesiology · 139d
Cleared Jan 06, 1993
TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES
K924195 · BTO
American Healthcare Corp.
Anesthesiology · 139d
Cleared Jan 06, 1993
DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT
K924674 · MRR
Genzyme Corp.
Chemistry · 112d
Cleared Jan 06, 1993
PREGNAGEN 1-STEP PREGNANCY TEST
K925189 · LCX
Biogenex Laboratories
Chemistry · 85d
Cleared Jan 06, 1993
ACTIVE RENIN IMMUNORADIOMETRIC ASSAY
K925998 · CIB
Nichols Institute Diagnostics
Chemistry · 40d
Cleared Jan 05, 1993
COBE PATIENT MONITORING PRODUCTS
K921343 · DRS
Cobe Cardiovascular, Inc.
Cardiovascular · 292d
Cleared Jan 05, 1993
LOW PROFILE GASTROMSTOMY DEVICE
K923474 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 175d
Cleared Jan 05, 1993
AMBU SINGLE PATIENT USE PEEP VALVE
K923976 · BYE
Ambu, Inc.
Anesthesiology · 151d
Cleared Jan 05, 1993
DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III
K926046 · JJY
Baxter Diagnostics, Inc.
Chemistry · 35d