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
83833–83856 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 1999
K-ASSAY ALPHA-1 AG
K993441 · LKL
Kamiya Biomedical Co.
Immunology · 43d
Cleared Nov 24, 1999
K-ASSAY ALPHA-1 AT
K993444 · DEM
Kamiya Biomedical Co.
Immunology · 43d
Cleared Nov 24, 1999
K-ASSAY HAPTOGLOBIN
K993480 · DAD
Kamiya Biomedical Co.
Immunology · 41d
Cleared Nov 24, 1999
POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS)
K993495 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 40d
Cleared Nov 24, 1999
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS)
K993502 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 40d
Cleared Nov 24, 1999
DIGITRAKPLUS HOLTER RECORDER
K993617 · MWJ
Braemar Corp.
Cardiovascular · 29d
Cleared Nov 24, 1999
DXP1000 HOLTER RECORDER
K993618 · MWJ
Braemar Corp.
Cardiovascular · 29d
Cleared Nov 24, 1999
N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS
K993637 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 27d
Cleared Nov 24, 1999
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
K993648 · MCW
Boston Scientific Corporation...
Cardiovascular · 26d
Cleared Nov 24, 1999
CT PERFUSION OPTION
K993791 · JAK
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Nov 24, 1999
SMART VESSEL ANALYSIS (SMART VA) OPTION
K993792 · JAK
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Nov 23, 1999
EASY-JET DEVICE
K972383 · KLZ
A.Stein - Regulatory Affairs Consulting
Ear, Nose, Throat · 880d
Cleared Nov 23, 1999
TRENDCARE CALIBRATOR MODEL SCU 7007
K983198 · CCC
Diametrics Medical, Ltd.
Anesthesiology · 438d
Cleared Nov 23, 1999
STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS
K990512 · KRI
Stoeckert Instrumente
Cardiovascular · 278d
Cleared Nov 23, 1999
SIRSCAN
K991473 · KZK
Intelligence Artificielle Applications
Microbiology · 210d
Cleared Nov 23, 1999
LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN...
K991906 · HIF
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 186d
Cleared Nov 23, 1999
ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS
K992235 · LZO
Corin USA
Orthopedic · 144d
Cleared Nov 23, 1999
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K992330 · JEY
Biomedics
Dental · 134d
Cleared Nov 23, 1999
CIDEX OPA SOLUTION TEST STRIP
K992341 · JOJ
Serim Research Corp.
General Hospital · 133d
Cleared Nov 23, 1999
AMORPHOUS DIAMOND COATED SCREW
K992538 · DZE
Nobel Biocare Uas, Inc.
Dental · 116d
Cleared Nov 23, 1999
ROCHE COBAS INTEGRA OPIATES 300/2000
K992890 · DJG
Roche Diagnostics Corp.
Toxicology · 88d
Cleared Nov 23, 1999
EBI SPINELINK SYSTEM
K992920 · MNI
Ebi, L.P.
Orthopedic · 85d
Cleared Nov 23, 1999
AX WORKSTATION DR-VIEWER SOFTWARE OPTION
K992925 · LLZ
Siemens Corp.
Radiology · 85d
Cleared Nov 23, 1999
TURBO 7000 SHAVER AND DRILL CONSOLE
K992994 · ERL
Gyrus Ent LLC
Ear, Nose, Throat · 77d