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
89713–89736 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 1998
ETEST CEFTRIAXONE
K981139 · JWY
Ab Biodisk
Microbiology · 63d
Cleared Jun 01, 1998
PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES
K981159 · LZA
Latexx Partners Bhd.
General Hospital · 62d
Cleared Jun 01, 1998
ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
K981230 · HSB
Biodynamic Technologies, Inc.
Orthopedic · 59d
Cleared Jun 01, 1998
MIRACLE MIX CAPSULE
K981370 · EMA
GC America, Inc.
Dental · 47d
Cleared Jun 01, 1998
ANATOMARK NONINVASIVE HEAD REFERENCE SYSTEM
K981398 · LNH
Interneuron Pharmaceuticals, Inc.
Radiology · 45d
Cleared Jun 01, 1998
DIASCREEN REAGENT STRIPS
K981555 · LJX
Chronimed, Inc.
Chemistry · 31d
Cleared May 29, 1998
B-D AUTO-INJECTOR
K974678 · KZH
Bd Becton Dickinson Vacutainer...
General Hospital · 165d
Cleared May 29, 1998
STRYKER SE5 ARTHROSCOPY SYSTEM WITH HERMES VOICE CONTROL
K974771 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 158d
Cleared May 29, 1998
ETEST CHLORAMPHENICAL
K980342 · JWY
Ab Biodisk
Microbiology · 121d
Cleared May 29, 1998
ETEST VANCOMYCIN
K980348 · JWY
Ab Biodisk
Microbiology · 121d
Cleared May 29, 1998
DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH...
K980780 · DSP
Datascope Corp.
Cardiovascular · 88d
Cleared May 29, 1998
J-FX BIPOLAR HEAD
K980801 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 88d
Cleared May 29, 1998
BABYTHERM 8000 LDR
K980886 · FMZ
Draeger Medical, Inc.
General Hospital · 81d
Cleared May 29, 1998
IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES
K980994 · FPA
Venetec Intl., Inc.
General Hospital · 73d
Cleared May 29, 1998
PEDIATRIC PRC
K981113 · MNH
Acromed Corp.
Orthopedic · 63d
Cleared May 29, 1998
OSTEOLOCK ACETABULAR CUP
K981201 · LZO
Howmedica Corp.
Orthopedic · 57d
Cleared May 29, 1998
CREATININE (CREA)
K981240 · CGX
Abbott Laboratories
Chemistry · 53d
Cleared May 29, 1998
GEEN MEDISOX
K981296 · DWL
Geen Healthcare, Inc.
General Hospital · 50d
Cleared May 29, 1998
MICRO-STRIP FOR COCAINE METABOLITES
K981388 · DIO
Microdiagnostics, Inc.
Toxicology · 43d
Cleared May 29, 1998
DISPOSABLE RE-NEW FORCEPS
K981389 · GEI
Microline Pentax, Inc.
General & Plastic Surgery · 43d
Cleared May 29, 1998
UROSURGE SPIRASTENT PLUS URETERAL STENT
K981489 · FAD
Urosurge, Inc.
Gastroenterology & Urology · 32d
Cleared May 29, 1998
UROSURGE FILASTENT URETERAL STENT
K981491 · FAD
Urosurge, Inc.
Gastroenterology & Urology · 32d
Cleared May 29, 1998
VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM
K981700 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 15d
Cleared May 28, 1998
SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496
K972502 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 329d