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
87961–87984 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 1998
IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5
K983970 · DDR
Diagnostic Products Corp.
Chemistry · 16d
Cleared Nov 25, 1998
ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05
K984070 · JJX
Bio-Rad
Chemistry · 9d
Cleared Nov 25, 1998
ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05
K984073 · JJX
Bio-Rad
Chemistry · 9d
Cleared Nov 24, 1998
ERCO-RIBBON
K981343 · LKY
Ercons, Inc.
Gastroenterology & Urology · 225d
Cleared Nov 24, 1998
ERCO-VAC
K981357 · LKY
Ercons, Inc.
Gastroenterology & Urology · 224d
Cleared Nov 24, 1998
BAXTER HEMOSTASIS VALVE INTRODUCERS
K981909 · DYB
Baxter Edwards
Cardiovascular · 176d
Cleared Nov 24, 1998
SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX...
K982416 · LYY
Shun Thai Rubber Gloves Industry Co.,...
General Hospital · 134d
Cleared Nov 24, 1998
PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE
K982536 · JAK
Siemens Corp.
Radiology · 126d
Cleared Nov 24, 1998
MICROMEDICS NASAL SEPTAL BUTTON
K982667 · LFB
Micromedics, Inc.
Ear, Nose, Throat · 116d
Cleared Nov 24, 1998
PHILIPS BUCKY VISION
K982795 · MQB
Philips Medical Systems, Inc.
Radiology · 106d
Cleared Nov 24, 1998
FLOWMATE II PLUS, MODEL #4000
K982956 · BZG
Spirometrics Medical Equipment Co.
Anesthesiology · 92d
Cleared Nov 24, 1998
ULTRASOUND WORKSTATION, UIWS-300A
K982976 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 90d
Cleared Nov 24, 1998
TUBING BLOOD FLOW METER MODEL NUMBER HD-800
K982986 · DPW
Koven Technology, Inc.
Radiology · 90d
Cleared Nov 24, 1998
IN-PROBE II URODYNAMIC SYSTEM
K983325 · FEN
Influence, Inc.
Gastroenterology & Urology · 63d
Cleared Nov 24, 1998
INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID...
K983819 · DSY
Intervascular, Inc.
Cardiovascular · 26d
Cleared Nov 24, 1998
DISTAFLO BYPASS GRAFT
K983861 · DSY
Impra, Inc.
Cardiovascular · 22d
Cleared Nov 24, 1998
ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05
K984072 · JJX
Bio-Rad
Chemistry · 8d
Cleared Nov 23, 1998
METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE...
K981249 · CAF
Instrumentation Industries, Inc.
Anesthesiology · 231d
Cleared Nov 23, 1998
AURORA
K981379 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 221d
Cleared Nov 23, 1998
M1145 (UPS1-1.25K-1G-MP) UPS
K981412 · CBK
Clary Corp.
Anesthesiology · 217d
Cleared Nov 23, 1998
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K981768 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 188d
Cleared Nov 23, 1998
SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6...
K982354 · HTN
Special Devices, Inc.
Orthopedic · 140d
Cleared Nov 23, 1998
ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES
K982965 · FWF
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 90d
Cleared Nov 23, 1998
ORATEC TAC-C, MONOPOLAR CAUTERY PROBE
K982971 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 90d