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
89377–89400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 1998
SOFTLIGHT Q-SWITCHED (ND:YAG) LASER
K971207 · GEX
Thermolase Corp.
General & Plastic Surgery · 412d
Cleared May 13, 1998
GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE
K971374 · HIH
Wilson Greatbatch Technologies, Inc.
Obstetrics & Gynecology · 394d
Cleared May 13, 1998
PFLEIDERER'S INTRATYMPANIC CATHETER
K974008 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 208d
Cleared May 13, 1998
ACCU-CHEK A1C HEMOGLOBIN TEST
K974491 · LCP
Boehringer Mannheim Corp.
Hematology · 166d
Cleared May 13, 1998
NIDEK PRIMA MODEL GYC-1500/2000
K980547 · GEX
Nidek, Inc.
General & Plastic Surgery · 90d
Cleared May 13, 1998
DURA-PATCH MODEL DP-XXX
K980548 · GXQ
Bridger Biomed, Inc.
Neurology · 90d
Cleared May 13, 1998
ETEST TROVAFLOXACIN
K980603 · JWY
Ab Biodisk
Microbiology · 85d
Cleared May 13, 1998
PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT,...
K980649 · LPL
CooperVision, Inc.
Ophthalmic · 83d
Cleared May 13, 1998
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
K981413 · DQY
Boston Scientific Scimed, Inc.
Cardiovascular · 23d
Cleared May 13, 1998
THIRD GENERATION PSA CONTROL MODULE
K981455 · JJY
Diagnostic Products Corp.
Chemistry · 20d
Cleared May 12, 1998
SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)
K971408 · GXN
Ikonos Corp.
Neurology · 391d
Cleared May 12, 1998
USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION...
K973820 · FAS
Circon Corp.
Gastroenterology & Urology · 217d
Cleared May 12, 1998
ARCHIMED 4210 AND 4220
K973922 · LOS
Biosound Esaote, Inc.
Cardiovascular · 209d
Cleared May 12, 1998
MEGAVAC SYSTEM
K974196 · LKY
Barry J. Kaplan, Inc.
Gastroenterology & Urology · 186d
Cleared May 12, 1998
PREMIER PLATINUM HPSA
K980076 · LYR
Meridian Diagnostics, Inc.
Microbiology · 124d
Cleared May 12, 1998
DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
K980337 · LJM
Helix Diagnostics, Inc.
Immunology · 104d
Cleared May 12, 1998
PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12...
K980530 · MPA
Peregrine Surgical , Ltd.
Ophthalmic · 90d
Cleared May 12, 1998
COLOSCREEN-ES
K980671 · KHE
Helena Laboratories
Hematology · 81d
Cleared May 12, 1998
ULTRA-BLASTER
K980726 · KOJ
Ultradent Products, Inc.
Dental · 77d
Cleared May 12, 1998
SERAQUEST ANTI-SSA
K980810 · LJM
Quest Intl., Inc.
Immunology · 70d
Cleared May 12, 1998
SERAQUEST ANTI-SM/RNP
K980811 · LKP
Quest Intl., Inc.
Immunology · 70d
Cleared May 12, 1998
MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE
K980857 · MKJ
Graphic Controls Corp.
Cardiovascular · 68d
Cleared May 12, 1998
HEMOCOR HPH MINI HEMOCONCENTRATOR
K980859 · KDI
Minntech Corp.
Gastroenterology & Urology · 68d
Cleared May 12, 1998
ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.
K981059 · LDP
Diagnostic Chemicals , Ltd.
Toxicology · 50d