FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
93481–93504 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 1997
CONTIDRAIN CATHETER
K964757 · EZL
Contimed, Inc.
Gastroenterology & Urology · 210d
Cleared Jun 25, 1997
CODMAN LUMBAR DRAINAGE CATHETER KIT
K964923 · JXG
Johnson & Johnson Professionals, Inc.
Neurology · 198d
Cleared Jun 25, 1997
AESUCLAP SOCON SPINAL SYSTEM
K970285 · MNH
Aesculap, Inc.
Orthopedic · 152d
Cleared Jun 25, 1997
CARDIOVIT CS-200
K970879 · LOS
Schiller America, Inc.
Cardiovascular · 107d
Cleared Jun 25, 1997
BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
K971139 · MBI
Boston Scientific Corp
Orthopedic · 89d
Cleared Jun 25, 1997
MULTITAK SS SUTURE SYSTEM
K971144 · MBI
Bonutti Research
Orthopedic · 89d
Cleared Jun 25, 1997
SPLITSCREEN (ME-975)
K971153 · LMD
Merlin Engineering Works, Inc.
Radiology · 89d
Cleared Jun 25, 1997
MULTIPICS(ME-977)
K971154 · LMD
Merlin Engineering Works, Inc.
Radiology · 89d
Cleared Jun 25, 1997
SATELLITE
K971331 · GWQ
Nicolet Biomedical, Inc.
Neurology · 76d
Cleared Jun 25, 1997
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON
K971541 · KPI
Hollister, Inc.
Gastroenterology & Urology · 58d
Cleared Jun 25, 1997
EMIT II OPIATES 300/2000 ASSAY
K971596 · DJG
Behring Diagnostics, Inc.
Toxicology · 55d
Cleared Jun 25, 1997
EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)
K971600 · DKB
Behring Diagnostics, Inc.
Toxicology · 55d
Cleared Jun 25, 1997
I-SCOPE OPHTHALMIC ENDOSCOPE
K971679 · MPA
Ophthalmic Technologies, Inc.
Ophthalmic · 49d
Cleared Jun 25, 1997
BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST
K971841 · LDJ
Bionike Laboratories, Inc.
Toxicology · 37d
Cleared Jun 24, 1997
SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION
K962811 · DXJ
Spacelabs Medical, Inc.
Cardiovascular · 341d
Cleared Jun 24, 1997
SMF TITANIUM (TI) ALLOY BONE SCREWS
K963546 · DZL
Synthes (Usa)
Dental · 292d
Cleared Jun 24, 1997
OPUS PSA TEST SYSTEM
K964595 · LTJ
Behring Diagnostics, Inc.
Immunology · 218d
Cleared Jun 24, 1997
POWDER - FREE LATEX EXAMINATION GLOVES APPLICATION
K964826 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 204d
Cleared Jun 24, 1997
MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14,...
K964974 · GKZ
Dako Corp.
Hematology · 194d
Cleared Jun 24, 1997
VENTED I.V. SET
K965027 · FPA
Jms Co., Ltd.
General Hospital · 189d
Cleared Jun 24, 1997
THAIRAPY VEST SYSTEM
K965192 · BYI
American Biosystems, Inc.
Anesthesiology · 182d
Cleared Jun 24, 1997
ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES
K970015 · LZA
Eci Medical Technologies, Inc.
General Hospital · 173d
Cleared Jun 24, 1997
FILTER
K970102 · CAH
Promedic, Inc.
General Hospital · 162d
Cleared Jun 24, 1997
LOW PROTEIN LATEX EXAMINATION GLOVES
K970222 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 154d