FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
128113–128136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1990
DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD
K896475 · IYT
Medipart Jerry Alexander
Radiology · 70d
Cleared Jan 22, 1990
DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD
K896476 · IYT
Medipart Jerry Alexander
Radiology · 70d
Cleared Jan 22, 1990
PORGES BIOPSY & FOREIGN BODY FORCEPS
K896502 · OCZ
Porges Corp.
Gastroenterology & Urology · 68d
Cleared Jan 22, 1990
TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR.
K896510 · CBN
Technical Medical Products, Inc.
Anesthesiology · 69d
Cleared Jan 22, 1990
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
K896547 · JOH
Bivona Medical Technologies
Anesthesiology · 68d
Cleared Jan 22, 1990
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
K896548 · JOH
Bivona Medical Technologies
Anesthesiology · 68d
Cleared Jan 22, 1990
MUCOUS TRAP
K896560 · BSY
Westmark, Sterile Packing Systems,...
Anesthesiology · 66d
Cleared Jan 22, 1990
ACCESS(TM), SOFTWARE RELEASE 4.11P
K896637 · LPH
Diasonics, Inc.
Radiology · 59d
Cleared Jan 22, 1990
EXT-600 TABLE, RADIOGRAPHIC, ELEVATING
K896665 · IZZ
Rms Div.
Radiology · 56d
Cleared Jan 22, 1990
COMPACT VIDEO IMAGER MP4000 SERIES III
K896683 · LMC
International Imaging Electronics
Radiology · 55d
Cleared Jan 22, 1990
MODEL 7-AT TREATMENT CHAMBER
K896721 · LGM
J. H. Emerson Co.
General Hospital · 55d
Cleared Jan 22, 1990
FILT-R-ALL BACTERIAL FILTER
K896832 · CAH
Inhalation Plastics
General Hospital · 48d
Cleared Jan 22, 1990
L.A.S.P. LUMBAR AND SACRAL PAD, REPOSITION. SNAP
K896936 · GXY
Labeltape Meditect, Inc.
Neurology · 40d
Cleared Jan 22, 1990
TRIMODE SP DENTAL INTRA ORAL X-RAY
K896963 · EAP
Tempo Technology, Inc.
Radiology · 38d
Cleared Jan 22, 1990
PATIENT EXAMINATION GLOVES
K897066 · LYY
Golden Gloves Intl.
General Hospital · 32d
Cleared Jan 22, 1990
VENTRESIGN STREP A TEST
K897083 · GTZ
Ventrex Laboratories, Inc.
Microbiology · 33d
Cleared Jan 22, 1990
ALLERCOAT MICROPLATE SYSTEM
K900028 · JJQ
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 19d
Cleared Jan 22, 1990
TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT
K900167 · DCF
Behring Diagnostics, Inc.
Immunology · 10d
Cleared Jan 20, 1990
EXERCISE EVALUATION SYSTEM 2010
K896345 · BZM
Medical Graphics Corp.
Anesthesiology · 78d
Cleared Jan 19, 1990
ESI MODEL MS-103
K885120 · GZT
Electrical Systems Div.
Neurology · 403d
Cleared Jan 19, 1990
COMPREHENSIVE SPINE MOTION ANALYZER
K894283 · KQX
Orthopedic Systems, Inc.
Neurology · 210d
Cleared Jan 19, 1990
CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATOR
K894600 · LFL
Valleylab, Inc.
General & Plastic Surgery · 183d
Cleared Jan 19, 1990
NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW.
K894631 · DPW
Nihon Kohden America, Inc.
Cardiovascular · 179d
Cleared Jan 19, 1990
BALLOON DILATATION CATHETER
K894944 · LIT
Peripheral Systems Group
Cardiovascular · 169d