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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
129073–129096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 1989
MULTIPLE MENTAL SPECTACLE FRAMES
K895300 · HQZ
Optica Trade S.A.
Ophthalmic · 27d
Cleared Sep 21, 1989
FLEX EYEWEAR FRAMES
K895371 · HQZ
Flex Eyewear, Inc.
Ophthalmic · 23d
Cleared Sep 21, 1989
QM300 CERULOPLASMIN ANTIBODY PACK
K895377 · DDB
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 22d
Cleared Sep 20, 1989
10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON
K892797 · DSP
Kontron Instruments, Inc.
Cardiovascular · 156d
Cleared Sep 20, 1989
9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON
K892798 · DSP
Kontron Instruments, Inc.
Cardiovascular · 156d
Cleared Sep 20, 1989
8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON
K892799 · DSP
Kontron Instruments, Inc.
Cardiovascular · 156d
Cleared Sep 20, 1989
PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE)
K893459 · DSY
Medtronic Vascular
Cardiovascular · 140d
Cleared Sep 20, 1989
OPUS MODELS 4033 AND 4034
K894267 · DXY
Ela Medical, Inc.
Cardiovascular · 90d
Cleared Sep 20, 1989
MEDTRONIC MODEL 5455S DISPOSABLE SURGICAL CABLE
K894981 · DSA
Medtronic Vascular
Cardiovascular · 43d
Cleared Sep 19, 1989
MEDI-TRACE ACCU-NATE DEVICE
K891193 · FPA
Graphic Controls Corp.
General Hospital · 197d
Cleared Sep 19, 1989
TERUFUSION THREE WAY STOPCOCK
K891234 · FMG
Terumo Medical Corp.
General Hospital · 196d
Cleared Sep 19, 1989
PERRY* STERILE X-AM* GLOVES
K891444 · LYY
Smith & Nephew Medical
General Hospital · 188d
Cleared Sep 19, 1989
MITEK ANCHOR
K892126 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 173d
Cleared Sep 19, 1989
DISPOSABLE LATEX EXAMINATION GLOVES
K893767 · LYY
Masif Healthcare Products Sdn. Bhd.
General Hospital · 123d
Cleared Sep 19, 1989
RMI ARTERIAL PERFUSION CANNULA
K894243 · DQR
Research Medical, Inc.
Cardiovascular · 90d
Cleared Sep 19, 1989
PVS DUAL CURE VENEER BONDING KIT
K894391 · KLE
Jelenko Co.
Dental · 64d
Cleared Sep 19, 1989
MAXIMUM CURE SEALANT WITH FLUORIDE
K894566 · DYH
Reliance Orthodontic Products, Inc.
Dental · 60d
Cleared Sep 19, 1989
MARDX LYME DISEASE IFA (IGM) TEST SYSTEM
K894609 · LSR
Mardx, Inc.
Microbiology · 61d
Cleared Sep 19, 1989
30-CS01, 30-CS02, 30-CS03 CONTROL SYRINGES
K894801 · FMF
Advance Medical Designs, Inc.
General Hospital · 53d
Cleared Sep 19, 1989
VARIOUS DISPOSABLE SURGICAL GARMENTS
K895235 · FYE
Protect Corp. of Indiana, Inc.
General & Plastic Surgery · 43d
Cleared Sep 18, 1989
CATHETER INTRODUCER SHEATH
K890766 · DYB
Applied Vascular Devices, Inc.
Cardiovascular · 215d
Cleared Sep 18, 1989
TRI-LUMEN INTRA VASCULAR BALLOON CATHETER
K891021 · DXE
Ideal Medical, Inc.
Cardiovascular · 202d
Cleared Sep 18, 1989
SRS-200 RADIOSURGERY SYSTEM
K891292 · IYE
Philips Medical Systems North...
Radiology · 192d
Cleared Sep 18, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892041 · LYY
United Gloves Sdn. Bhd.
General Hospital · 171d