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
86617–86640 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 1999
SMARTBOND
K981036 · DYH
Gac Intl., Inc.
Dental · 382d
Cleared Apr 05, 1999
ANGIO-CT MIYABI
K990491 · IXI
Siemens Medical Solutions USA, Inc.
Radiology · 47d
Cleared Apr 05, 1999
GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH
K990567 · FRG
Global Healthcare, Inc.
General Hospital · 41d
Cleared Apr 04, 1999
DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
K990064 · HQR
Ophthalmic Technologies, Inc.
Ophthalmic · 86d
Cleared Apr 04, 1999
S.P.A.R STERILE AMBULATORY RESERVOIR
K990091 · MRZ
Faulding Pharmaceutical Co.
General Hospital · 83d
Cleared Apr 02, 1999
SECOND WIND AIR PURIFIER
K980745 · FRA
Monagan Ent., Inc.
General Hospital · 400d
Cleared Apr 02, 1999
FOCUS PILOT CONTOURING WORKSTATION
K981535 · IYE
Computerized Medical Systems, Inc.
Radiology · 338d
Cleared Apr 02, 1999
ULTRA CARE NON-STERILE POWDER FREE (GREEN) NATURAL RUBBER LATEX PATIENT...
K982505 · LYY
Tillotson Healthcare Corp.
General Hospital · 256d
Cleared Apr 02, 1999
SPQ TEST SYSTEM
K982708 · DFC
DiaSorin, Inc.
Chemistry · 241d
Cleared Apr 02, 1999
SMARTCELL PROCESSING SYSTEM
K983022 · CAC
Harvest Technologies, LLC
Anesthesiology · 214d
Cleared Apr 02, 1999
TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRADE, VERSION 1.20
K983115 · JAQ
Nucletron Corp.
Radiology · 210d
Cleared Apr 02, 1999
ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068
K983337 · JAQ
Nucletron Corp.
Radiology · 191d
Cleared Apr 02, 1999
PLATO BRACHYTHERAPHY, MODEL V. 14.0
K983343 · MUJ
Nucletron Corp.
Radiology · 191d
Cleared Apr 02, 1999
THERAPEP
K983467 · BWF
Dhd Healthcare Corp.
Anesthesiology · 189d
Cleared Apr 02, 1999
STERICHEK TOTAL CHLORINE TEST KIT
K983997 · MSY
Environmental Test Systems, Inc.
Gastroenterology & Urology · 143d
Cleared Apr 02, 1999
STERILE BACK SURGICAL GOWN WITH HAND TOWEL
K984422 · FYA
Medical Sterilization, Inc.
General Hospital · 113d
Cleared Apr 02, 1999
TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K984513 · JTN
Oxoid , Ltd.
Microbiology · 105d
Cleared Apr 02, 1999
DCI ENDOSCOPE
K990004 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 88d
Cleared Apr 02, 1999
MULTI-CURE COMPOSITE CEMENT
K990314 · EBF
Medental Intl.
Dental · 60d
Cleared Apr 02, 1999
POWDER FREE NITRILE EXAMINATION GLOVES
K990495 · LZA
Flexitech Sdn. Bhd.
General Hospital · 44d
Cleared Apr 02, 1999
PREPOWDERED NITRILE EXAMINATION GLOVES
K990499 · LZA
Flexitech Sdn. Bhd.
General Hospital · 44d
Cleared Apr 02, 1999
POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM
K990501 · LYY
Flexitech Sdn. Bhd.
General Hospital · 44d
Cleared Apr 02, 1999
PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100...
K990502 · LYY
Flexitech Sdn. Bhd.
General Hospital · 44d
Cleared Apr 02, 1999
HELIOFORM GOLD-BASED ALLOY
K990670 · EJT
C. Hafner GmbH & Co.
Dental · 31d