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
79129–79152 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 2001
PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS...
K010784 · MUJ
Nucletron Corp.
Radiology · 26d
Cleared Apr 09, 2001
REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
K001352 · DHC
Corgenix, Inc.
Immunology · 346d
Cleared Apr 09, 2001
TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS
K002902 · MSD
The Kendall Company
Gastroenterology & Urology · 203d
Cleared Apr 09, 2001
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL...
K002981 · GEI
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 196d
Cleared Apr 09, 2001
MIMIX BONE REPLACEMENT SYSTEM
K003494 · LYC
Biomet, Inc.
Dental · 147d
Cleared Apr 09, 2001
MODIFICATION TO SYNTHES (USA) POLYPIN
K003527 · HTY
Synthes (Usa)
Orthopedic · 144d
Cleared Apr 09, 2001
RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR
K003676 · GEI
Rita Medical Systems
General & Plastic Surgery · 131d
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