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
94417–94440 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1997
IS-ANTI-SM/RNP (720-270)
K970238 · LLL
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-SCL-70 TEST SYSTEM (720-280)
K970239 · LLL
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
CLINISTRIP
K970250 · JIL
Teco Diagnostics
Chemistry · 76d
Cleared Apr 08, 1997
E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET
K970259 · FPA
Becton Dickinson Vascular Access, Inc.
General Hospital · 75d
Cleared Apr 08, 1997
ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST
K970265 · DKZ
Drial Consultants, Inc.
Toxicology · 75d
Cleared Apr 08, 1997
HYDROFLEX
K970656 · ELW
GC America, Inc.
Dental · 46d
Cleared Apr 08, 1997
CARDIOISOZYME, CK/LD ISOENZYME CONTROL
K970856 · JJT
Medical Analysis Systems, Inc.
Chemistry · 29d
Cleared Apr 08, 1997
SPINALSCOPICS
K970862 · JJY
Quantimetrix Corp.
Chemistry · 32d
Cleared Apr 08, 1997
STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C...
K970921 · JIX
Alko Diagnostic Corp.
Chemistry · 27d
Cleared Apr 08, 1997
ORGENTEC MICRO-ALBUMIN EIA ASSAY
K970932 · JIR
American Laboratory Products Co., Ltd.
Chemistry · 47d
Cleared Apr 08, 1997
CERTAIN COMPLETE LEVELS 1,2, AND 3
K970956 · JJY
Chiron Diagnostics Corp.
Chemistry · 22d
Cleared Apr 08, 1997
DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404)
K971058 · DIF
Medical Analysis Systems, Inc.
Chemistry · 15d
Cleared Apr 07, 1997
AESOP SYSTEM AND ACCESSORIES
K963126 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 238d
Cleared Apr 07, 1997
RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY...
K970088 · HWE
Richard Wolf Medical Instruments Corp.
Orthopedic · 87d
Cleared Apr 07, 1997
LASERSCOPE AUTOMATIC EYE PROTECTION FILTER
K970157 · GEX
Laserscope
General & Plastic Surgery · 81d
Cleared Apr 07, 1997
LUMBAR PUNCTURE KIT
K970287 · FMJ
B.Braun Medical, Inc.
General Hospital · 73d
Cleared Apr 07, 1997
DOWNSCAN 120
K970451 · LLZ
Merlin Engineering Works, Inc.
Radiology · 60d
Cleared Apr 07, 1997
SYSTEM B HEAT SOURCE
K970715 · EAT
Sybron Dental Specialties, Inc.
Dental · 39d
Cleared Apr 04, 1997
FLEXIBLE DILATING SHEATH
K945586 · DRE
Med Institute, Inc.
Cardiovascular · 872d
Cleared Apr 04, 1997
SYRINGEFILTER
K960928 · BSN
Arbor Technologies, Inc.
Anesthesiology · 393d
Cleared Apr 04, 1997
TONOCAP, TC-200 AND ACCESSORY CATHETERS
K962638 · CCK
Instrumentarium Corp.
Anesthesiology · 273d
Cleared Apr 04, 1997
LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY
K963076 · HET
Louisville Laboratories, Inc.
Obstetrics & Gynecology · 240d
Cleared Apr 04, 1997
HEARTPORT ENDOAORTIC CLAMP
K964161 · DXC
Heartport, Inc.
Cardiovascular · 169d
Cleared Apr 04, 1997
VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101
K964360 · BZC
Novametrix Medical Systems, Inc.
Anesthesiology · 154d