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
83497–83520 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1999
HARDYDISK AMIKACIN 30MCG
K993993 · JTN
Hardy Diagnostics
Microbiology · 33d
Cleared Dec 27, 1999
GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 435
K994075 · GEI
Geiger Medical Technologies, Inc.
General & Plastic Surgery · 25d
Cleared Dec 27, 1999
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.
K994149 · GWJ
Bio-Logic Systems Corp.
Neurology · 19d
Cleared Dec 27, 1999
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE
K994166 · KNS
Gyrus Medical , Ltd.
Gastroenterology & Urology · 18d
Cleared Dec 23, 1999
FASTSEAL CHEST WOUND DRESSING
K990079 · MGP
Greenfield Medical Technologies, Inc.
General & Plastic Surgery · 346d
Cleared Dec 23, 1999
OMNICORDER BIOSCAN SYSTEM
K990416 · LHQ
Omnicorder Technologies, Inc.
Radiology · 316d
Cleared Dec 23, 1999
PHARMASEED, MODEL BT-125-1
K992008 · KXK
Syncor Pharmaceuticals, Inc.
Radiology · 191d
Cleared Dec 23, 1999
MPM REGENECARE WOUND GEL
K992074 · MGQ
Mpm Medical., Inc.
General & Plastic Surgery · 188d
Cleared Dec 23, 1999
SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE...
K993209 · GEX
Thermolase Corp.
General & Plastic Surgery · 90d
Cleared Dec 23, 1999
DUCPREP BREAST ASPIRATOR, MODEL PMPO2
K993342 · KNW
Windy Hill Technology, Inc.
Gastroenterology & Urology · 79d
Cleared Dec 23, 1999
THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP
K993424 · FZP
Y-Clip Associates
General & Plastic Surgery · 72d
Cleared Dec 23, 1999
O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER
K993651 · GBM
Sc Hennig Enterprises Europe Srl
Gastroenterology & Urology · 55d
Cleared Dec 23, 1999
SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM
K993731 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Dec 23, 1999
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K994068 · FGE
Cordis Corp.
Gastroenterology & Urology · 21d
Cleared Dec 22, 1999
GUGLIELMI DETACHABLE (GDC)
K991139 · HCG
Boston Scientific, Target
Neurology · 261d
Cleared Dec 22, 1999
STAT-SHELL DISPOSABLE SPO2 SENSOR
K992092 · DQA
Epic Medical Equipment Services, Inc.
Anesthesiology · 184d
Cleared Dec 22, 1999
SPO2 WRAP SENSOR
K992211 · DQA
Epic Medical Equipment Services, Inc.
Anesthesiology · 174d
Cleared Dec 22, 1999
HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED...
K992390 · KGE
Telemed Systems, Inc.
Gastroenterology & Urology · 156d
Cleared Dec 22, 1999
5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X...
K992402 · KNS
Telemed Systems, Inc.
Gastroenterology & Urology · 156d
Cleared Dec 22, 1999
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM
K992587 · LSE
Stellar Bio Systems, Inc.
Microbiology · 142d
Cleared Dec 22, 1999
PARAGON LENS CARRIER
K993486 · LRX
Paragon Vision Sciences
Ophthalmic · 68d
Cleared Dec 22, 1999
PARAGON LENS VIAL
K993487 · LRX
Paragon Vision Sciences
Ophthalmic · 68d
Cleared Dec 22, 1999
SPACE-OR RETRACTOR
K993544 · FFO
Advanced Surgical Concepts (Asc)
Gastroenterology & Urology · 64d
Cleared Dec 22, 1999
ENIGMA HI-BASE DENTURE BASE MATERIAL
K993717 · EBI
Davis Schottlander & Davis, Ltd.
Dental · 49d