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
89785–89808 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 1998
UROMED SLING KIT
K980717 · KNA
Uromed Corp.
Obstetrics & Gynecology · 87d
Cleared May 22, 1998
ACCU-CHEK COMFORT CURVE TEST STRIPS
K980731 · LFR
Boehringer Mannheim Corp.
Chemistry · 86d
Cleared May 22, 1998
IMPLEX CONTINUUM KNEE- HEDROCEL REVISION FEMORAL SPACERS
K980781 · JWH
Implex Corp.
Orthopedic · 81d
Cleared May 22, 1998
ALPHATEC WIRE EXTERNAL FIXATION SYSTEM
K980788 · JDW
Alphatec Mfg., Inc.
Orthopedic · 81d
Cleared May 22, 1998
MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION
K980858 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 78d
Cleared May 22, 1998
CLEAR (TM) SPECIAL NIT COMB
K981037 · LJL
Care Technologies, Inc.
General Hospital · 64d
Cleared May 22, 1998
APR -T REVISION HIP STEM
K981211 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 50d
Cleared May 22, 1998
STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)
K981341 · DJG
OraSure Technologies, Inc.
Toxicology · 39d
Cleared May 21, 1998
BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS
K970968 · HET
Guenter Bissinger Medizintechnik GmbH
Obstetrics & Gynecology · 430d
Cleared May 21, 1998
FAST-CATH (TM) INTRA-CARDIAC INTRODUCER
K973840 · DYB
Daig Corp.
Cardiovascular · 225d
Cleared May 21, 1998
NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM
K973929 · IPF
Neotonus, Inc.
Physical Medicine · 218d
Cleared May 21, 1998
PLUS REUSABLE RESUSCITATOR
K974141 · BTM
Schiff & Co.
Anesthesiology · 199d
Cleared May 21, 1998
SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE
K974571 · FPA
Baxter Healthcare Corp
General Hospital · 164d
Cleared May 21, 1998
COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA...
K974695 · CKB
Roche Diagnostic Systems, Inc.
Chemistry · 156d
Cleared May 21, 1998
FLEXIBLE FIBERSCOPES AND ACCESSORIES
K980401 · FAJ
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 108d
Cleared May 21, 1998
SPYROSORB FOAM ISLAND WOUND DRESSING
K980673 · KMF
Innovative Technologies (Us), Inc.
General & Plastic Surgery · 90d
Cleared May 21, 1998
SPIGAL NEEDLE
K980676 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 90d
Cleared May 21, 1998
NEOCOLLOID, ORTHOPRINT
K981091 · ELW
Zhermack S.P.A.
Dental · 57d
Cleared May 20, 1998
ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER
K972595 · BSP
Avid N.I.T., Inc.
Anesthesiology · 313d
Cleared May 20, 1998
SKINGARD TPF/AOSSTEX TPF/SENSIFREE/ESSENTIAL TPF/AMERIGLO TPF LATEX...
K973615 · LYY
Macro Rubber Industrial, Inc.
General Hospital · 239d
Cleared May 20, 1998
PINPOINT
K974513 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 170d
Cleared May 20, 1998
PHOTODERM HR SYSTEM
K974536 · GEX
Esc Medical Systems , Ltd.
General & Plastic Surgery · 169d
Cleared May 20, 1998
SIS HERNIA REPAIR DEVICE
K974540 · FTL
Sentron Medical, Inc.
General & Plastic Surgery · 168d
Cleared May 20, 1998
ULTRA BILI LIGHT
K974830 · LBI
Physician Engineered Products, Inc.
General Hospital · 147d