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
95833–95856 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 1996
SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2
K963543 · JIX
Sigma Diagnostics, Inc.
Chemistry · 56d
Cleared Oct 30, 1996
BIODERM PVP FOAM WOUND DRESSING
K963602 · KMF
Bioderm, Inc.
General & Plastic Surgery · 51d
Cleared Oct 30, 1996
VISUALINE COMBO V (COCAINE/THC) TEST
K963606 · LDJ
Sun Biomedical Laboratories, Inc.
Chemistry · 51d
Cleared Oct 30, 1996
INSTANT COLD PACK
K963666 · IMD
Kick Ice, Inc.
Physical Medicine · 47d
Cleared Oct 30, 1996
LEVO COMPACT LC
K963816 · IPL
Levo USA
Physical Medicine · 37d
Cleared Oct 30, 1996
AXSYM FREE TRIIODOTHYRONINE (FREE T3)
K963827 · CDP
Abbott Laboratories
Chemistry · 36d
Cleared Oct 30, 1996
IMX FREE TRIIODOTHYRONINE (FREE T3)
K963833 · CDP
Abbott Laboratories
Chemistry · 36d
Cleared Oct 29, 1996
PRESSURE STOPCOCK/MANIFOLD
K960431 · FPA
Scientific Device Manufacturer, LLC
General Hospital · 272d
Cleared Oct 29, 1996
DEFIBRILLATOR ANALYZER, DELTA 1000
K961595 · DRL
Netech Corp.
Cardiovascular · 188d
Cleared Oct 29, 1996
ELS AUTOMATIC TUBING CLAMP SYSTEM
K961598 · KRL
Rocky Mountain Research, Inc.
Cardiovascular · 203d
Cleared Oct 29, 1996
SONOLINE ELEGRA WITH SIESCAPE FEATURE
K961833 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 169d
Cleared Oct 29, 1996
PICO MODELS 30, 50, 70
K962158 · JKA
Radiometer America, Inc.
Chemistry · 147d
Cleared Oct 29, 1996
BARD TIGER GUIDEWIRE MODEL 000540
K962178 · OCY
C.R. Bard, Inc.
Gastroenterology & Urology · 145d
Cleared Oct 29, 1996
CEDIA CARDIAC TDM MULTI-CALS
K962269 · JIX
Boehringer Mannheim Corp.
Toxicology · 138d
Cleared Oct 29, 1996
HEARSAVER
K962292 · EWD
Emtech Laboratories
Ear, Nose, Throat · 137d
Cleared Oct 29, 1996
STERILE LATEX SURGICAL, SOLD UNDER BRAND NAMES SAVACARE AND ROGUMED
K962724 · KGO
Sonnheim Medikal GmbH
General Hospital · 106d
Cleared Oct 29, 1996
MINI SAMPLE PROCESSOR
K962859 · JQW
Cavro Scientific Instruments, Inc.
Chemistry · 99d
Cleared Oct 29, 1996
HELAX TMS BRACHYTHERAPY, VERSION 3.0
K962892 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 97d
Cleared Oct 29, 1996
GC BASELINE
K963144 · EBI
GC America, Inc.
Dental · 77d
Cleared Oct 29, 1996
ALGINMAX, ORTHOCHROME
K963205 · ELW
American Tooth Industries
Dental · 81d
Cleared Oct 29, 1996
CEDIA N-ACETYLPROCAINAMIDE ASSAY
K963306 · LAR
Boehringer Mannheim Corp.
Toxicology · 68d
Cleared Oct 29, 1996
MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED...
K963378 · FMQ
Medline Industries, Inc.
General Hospital · 63d
Cleared Oct 29, 1996
MEDLINE OPEN END FINGER CONTROL MITT
K963504 · FMQ
Medline
General Hospital · 56d
Cleared Oct 29, 1996
ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY...
K963528 · FMQ
Alimed, Inc.
General Hospital · 55d