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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
140833–140856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 1987
INTRAMEDULLARY NAIL
K870040 · HSB
The Deca Co.
Orthopedic · 80d
Cleared Mar 26, 1987
MODIFIED TRACHEAL TUBE WITH SALTZMAN E.A.R.(TM)
K870255 · BZT
Transcor, Inc.
Anesthesiology · 63d
Cleared Mar 26, 1987
ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE
K870775 · HQE
Entravision, Inc.
Ophthalmic · 28d
Cleared Mar 26, 1987
NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100
K870806 · HQC
United Surgical Corp.
Ophthalmic · 28d
Cleared Mar 26, 1987
BIO-VENT REUTER BOBBIN TUBE
K870877 · ETD
Richards Medical Co., Inc.
Ear, Nose, Throat · 23d
Cleared Mar 25, 1987
AGAR 7K TENS INSTRUMENT
K862454 · GZJ
Solcoor, Inc.
Neurology · 271d
Cleared Mar 25, 1987
INSALL/BURSTEIN(TM)* II TIBIAL WEDGES
K862632 · HSX
Zimmer, Inc.
Orthopedic · 258d
Cleared Mar 25, 1987
CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS
K864662 · LJP
American Micro Scan
Microbiology · 117d
Cleared Mar 25, 1987
ALADIN (TM)
K865062 · LRG
Analytical Products, Inc.
Microbiology · 91d
Cleared Mar 25, 1987
KAMINSKY COMBINATION STENT & INJECTION CATHETER
K865085 · FAD
Van-Tec, Inc.
Gastroenterology & Urology · 85d
Cleared Mar 25, 1987
VAN-TEC DOUBLE SHEATH GRASPING FORCEPS
K865087 · OCZ
Van-Tec, Inc.
Gastroenterology & Urology · 85d
Cleared Mar 25, 1987
IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE
K870029 · GWC
American Micro Scan
Microbiology · 79d
Cleared Mar 25, 1987
VP2000 INFUSION PUMP
K870279 · FRN
Vickers , Ltd.
General Hospital · 57d
Cleared Mar 25, 1987
BELMONT, PODIATRY X-RAY - REMEX, MODEL PD75
K870300 · KPR
Belmont Equipment Corp.
Radiology · 56d
Cleared Mar 25, 1987
DD-VCR-64
K870381 · GWK
Grass-Telefactor Product Group
Neurology · 55d
Cleared Mar 25, 1987
VAN-TEC POSITIVE OPEN SEGURA BASKET
K870615 · FFL
Van-Tec, Inc.
Gastroenterology & Urology · 41d
Cleared Mar 25, 1987
GUIDE WIRE
K870664 · DQX
Datascope Corp.
Cardiovascular · 34d
Cleared Mar 25, 1987
VAN-TEC PROSTATE BIOPSY NEEDLE
K870698 · KNN
Van-Tec, Inc.
Physical Medicine · 34d
Cleared Mar 25, 1987
PROSTATIC ASPIRATION BIOPSY SET
K870735 · KNW
Van-Tec, Inc.
Gastroenterology & Urology · 28d
Cleared Mar 25, 1987
MEDSURG CHIBA PTC NEEDLE
K870893 · GAA
Medsurg Industries, Inc.
General & Plastic Surgery · 20d
Cleared Mar 25, 1987
EDCOOL AND EDCOOL JR. INSTANT COLD PACK
K871006 · IMP
Advantage Credit Services, Inc.
Physical Medicine · 12d
Cleared Mar 25, 1987
CONTINUOUS PASSIVE MOTION PATIENT KIT OR RE. PAD
K871012 · BXB
Cropper Medical, Inc.
Physical Medicine · 12d
Cleared Mar 25, 1987
CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREW
K871037 · HWC
Concept, Inc.
Orthopedic · 8d
Cleared Mar 25, 1987
URINE METER, 250CC
K871042 · KNX
Salt Creek Medical Technologies
Gastroenterology & Urology · 8d