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
78601–78624 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K010922 · MNI
Endius, Inc.
Orthopedic · 71d
Cleared Jun 06, 2001
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
K010953 · GKZ
Abbott Laboratories
Hematology · 68d
Cleared Jun 06, 2001
STA-LIATEST FREE PROTEIN S TEST KIT
K010963 · GGP
Diagnostica Stago, Inc.
Hematology · 68d
Cleared Jun 06, 2001
THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
K011055 · FCM
Go Medical Industries Pty. , Ltd.
Gastroenterology & Urology · 61d
Cleared Jun 06, 2001
INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
K011057 · PJD
OraSure Technologies, Inc.
Toxicology · 61d
Cleared Jun 06, 2001
TPO IGG ANTIBODY EIA TEST
K011082 · JZO
Scimedx Corp.
Immunology · 57d
Cleared Jun 06, 2001
BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
K011390 · MBI
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared Jun 06, 2001
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
K011437 · MNI
Interpore Cross Intl.
Orthopedic · 27d
Cleared Jun 06, 2001
QED DIODE DETECTORS, MODELS 1112-1116
K011466 · LNH
Sun Nuclear Corp.
Radiology · 23d
Cleared Jun 06, 2001
PINNACLE MAGNETIC RESONANCE IMAGING SCANNER
K011485 · LNH
Fonar Corp.
Radiology · 22d
Cleared Jun 06, 2001
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
K011528 · DLZ
Syva Co.
Chemistry · 20d
Cleared Jun 05, 2001
STRYKER PAINPUMP PCA
K003543 · FRN
Stryker Instruments
General Hospital · 200d
Cleared Jun 05, 2001
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345
K010429 · MMI
Beckman Coulter, Inc.
Chemistry · 112d
Cleared Jun 05, 2001
HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM
K010682 · MUJ
Mds Nordion
Radiology · 90d
Cleared Jun 05, 2001
MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
K010701 · LYC
Medtronic Sofamor Danek USA, Inc.
Dental · 89d
Cleared Jun 05, 2001
PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
K010824 · MEB
Science Incorporated
General Hospital · 78d
Cleared Jun 05, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011029 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 61d
Cleared Jun 05, 2001
DELDENT ULTRASONIC INSERTS
K011179 · ELC
Deldent , Ltd.
Dental · 49d
Cleared Jun 05, 2001
POWDER-FREE VINYL EXAM GLOVE, YELLOW
K011413 · LYZ
Heyuan Hongli Industries, Inc.
General Hospital · 28d
Cleared Jun 05, 2001
POWDERED VINAL EXAM GLOVES
K011414 · LYZ
Heyuan Hongli Industries, Inc.
General Hospital · 28d
Cleared Jun 05, 2001
CARMEN
K011425 · EIH
Dentaurum, Inc.
Dental · 27d
Cleared Jun 05, 2001
TRICERAM
K011428 · EIH
Dentaurum, Inc.
Dental · 27d
Cleared Jun 05, 2001
ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
K011442 · FRN
Abbott Laboratories
General Hospital · 26d
Cleared Jun 05, 2001
POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING...
K011563 · LYY
U.O.P. Rubber Products Sdn Bhd
General Hospital · 15d