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
93913–93936 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 04, 1997
SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE,...
K965083 · ELW
S.S. White Mfg., Ltd.
Dental · 106d
Cleared Apr 04, 1997
SHARPSITE AC
K965233 · EOB
Xomed, Inc.
Ear, Nose, Throat · 94d
Cleared Apr 04, 1997
KODAK EKTASIAN HG FILM (EHG-15)
K970154 · IWZ
Eastman Kodak Company
Radiology · 78d
Cleared Apr 04, 1997
IMEX FUTURALDOP PRO
K970156 · IYO
Imex Medical Systems, Inc.
Radiology · 78d
Cleared Apr 04, 1997
CAVITRON JET WITH SPS SYSTEM
K970342 · ELC
Dentsply Intl.
Dental · 65d
Cleared Apr 04, 1997
PICTURE ARCHIVING & COMMUNICATIONS DEVICE
K970534 · LLZ
Multimedia Solutions
Radiology · 51d
Cleared Apr 04, 1997
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K970606 · JAK
GE Medical Systems
Radiology · 45d
Cleared Apr 04, 1997
EASY CAM
K970626 · EIA
I.C.S.
Dental · 44d
Cleared Apr 04, 1997
CLINITEK HCG TEST STRIPS
K971209 · JHI
Bayer Corp.
Chemistry · 2d