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

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176,076 results
80257–80280 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 2001
ENT ENDOSCOPES
K003830 · EOB
Global Endoscopy, Inc.
Ear, Nose, Throat · 119d
Cleared Apr 09, 2001
REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)
K010086 · GWQ
Excel Tech. , Ltd.
Neurology · 88d
Cleared Apr 09, 2001
ICG MODULE
K010164 · DSB
General Electric Medical Systems...
Cardiovascular · 81d
Cleared Apr 09, 2001
XTRACTOR, MODEL M143
K010220 · GCJ
Instruments Medicaux G.B., Inc.
General & Plastic Surgery · 75d
Cleared Apr 09, 2001
BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265
K010265 · GEI
Baylis Medical Co., Inc.
General & Plastic Surgery · 73d
Cleared Apr 09, 2001
STA-QUALITY HBPM/LMWH KIT
K010324 · GGN
Diagnostica Stago, Inc.
Hematology · 66d
Cleared Apr 09, 2001
MULTIPLE (IZON DNA BLOOD COLLECTION KIT)
K010328 · PJE
Izon Business Products, Inc.
Chemistry · 66d
Cleared Apr 09, 2001
STA -CALIBRATOR HBPM/LMWH KIT
K010350 · GGN
Diagnostica Stago, Inc.
Hematology · 63d
Cleared Apr 09, 2001
ETEST MEROPENEM
K010363 · JWY
Ab Biodisk
Microbiology · 61d
Cleared Apr 09, 2001
ATAC PAK AST REAGENT KIT
K010488 · CIT
Elan Holdings, Inc.
Chemistry · 48d
Cleared Apr 09, 2001
KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP
K010569 · GCJ
Karl Storz Endoscopy
General & Plastic Surgery · 42d
Cleared Apr 09, 2001
BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160
K010570 · LNH
Mri Devices Corp.
Radiology · 42d
Cleared Apr 09, 2001
POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
K010671 · LYZ
Tong Ruhn Medical Products Co., Ltd.
General Hospital · 34d
Cleared Apr 09, 2001
POWDER FREE TEXTURED VINYL EXAMINATION GLOVES
K010830 · LYZ
General Gloves Corp.
General Hospital · 20d
Cleared Apr 09, 2001
NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
K010909 · GAW
Tyco Healthcare Group LP
General & Plastic Surgery · 14d
Cleared Apr 09, 2001
AMS SACRAL COLPOPEXY SLING, MODEL 72403501
K010931 · OTO
American Medical Systems, Inc.
Obstetrics & Gynecology · 12d
Cleared Apr 06, 2001
TCOYF FERTILITY SOFTWARE VERSION 1.0
K002726 · LHD
Ovusoft, LLC
Obstetrics & Gynecology · 218d
Cleared Apr 06, 2001
PNS MAGNETIC STIMULATOR SYSTEM
K002889 · KOI
Neotonus, Inc.
Anesthesiology · 203d
Cleared Apr 06, 2001
LPC-PLUS ACETABULAR CUP
K003274 · LZO
Plus Orthopedics
Orthopedic · 170d
Cleared Apr 06, 2001
PREAMP CABLE, MODEL B400-1011PA
K003542 · DQA
Beta Biomed Services, Inc.
Anesthesiology · 140d
Cleared Apr 06, 2001
AVON PATELLO-FEMORAL JOINT PROSTHESIS
K010100 · KRR
Howmedica Osteonics Corp.
Orthopedic · 85d
Cleared Apr 06, 2001
ARTHREX UNIVERS 30 SHOULDER PROSTHESIS
K010124 · KWS
Arthrex, Inc.
Orthopedic · 80d
Cleared Apr 06, 2001
DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER
K010171 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 78d
Cleared Apr 06, 2001
TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES...
K010776 · MNH
Corin USA
Orthopedic · 23d