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
83617–83640 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 2000
PLAIN/CHROMIC CATGUT
K994002 · GAL
Trading Consultants and Distributors...
General & Plastic Surgery · 72d
Cleared Feb 04, 2000
MALLORY/HEAD SMOOTH FEMORAL COMPONENT
K994007 · JDI
Biomet, Inc.
Orthopedic · 72d
Cleared Feb 04, 2000
KARL STORZ AUTOCLAVABLE CAMERA HEAD
K994090 · FET
Karl Storz Imaging, Inc.
Gastroenterology & Urology · 63d
Cleared Feb 04, 2000
MR ENHANCER
K994117 · LNH
I.Z.I. Corp.
Radiology · 60d
Cleared Feb 04, 2000
COALESCENT SURGICAL SUTURED-CLIP
K994160 · FZP
Coalescent Surgical
General & Plastic Surgery · 57d
Cleared Feb 04, 2000
INTURIS SUITE
K994210 · LLZ
Philips Medical Systems, Inc.
Radiology · 52d
Cleared Feb 04, 2000
ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285
K994211 · KKX
Dentsply Intl.
General Hospital · 52d
Cleared Feb 04, 2000
DIMENSION TRNF FLEX REAGENT CARTRIDGE
K994294 · DDG
Dade Behring, Inc.
Immunology · 45d
Cleared Feb 04, 2000
CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM
K994315 · MOS
Siemens Medical Solutions USA, Inc.
Radiology · 44d
Cleared Feb 04, 2000
DOGBONE ACFS
K994383 · KWQ
Theken Surgical
Orthopedic · 38d
Cleared Feb 04, 2000
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
K994438 · MQM
Spectrx, Inc.
Chemistry · 36d
Cleared Feb 03, 2000
MODIFICATION TO ISOBAR SPINAL SYSTEM
K000020 · MNH
Encore Orthopedics, Inc.
Orthopedic · 30d
Cleared Feb 03, 2000
EBI XFIX DFS RAIL SYSTEM
K000083 · KTT
Ebi, L.P.
Orthopedic · 22d
Cleared Feb 03, 2000
SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
K000089 · HWC
Synthes (Usa)
Orthopedic · 22d
Cleared Feb 03, 2000
PRO-TORQ
K000120 · EBW
Micro Motors, Inc.
Dental · 16d
Cleared Feb 03, 2000
DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
K000172 · HRY
DePuy Orthopaedics, Inc.
Orthopedic · 14d
Cleared Feb 03, 2000
TED 200T7 OXYGEN MONITOR
K990403 · CCL
Teledyne Electronic Technologies
Anesthesiology · 359d
Cleared Feb 03, 2000
SD-730 IF-SDS, PERFECT PULSE IF-SDS
K992652 · LIH
Skylark Device & Systems Co., Ltd.
Neurology · 181d
Cleared Feb 03, 2000
T-2000-POWER TILT SEATING SYSTEM, MODELS ARD-TSTORM, ARD-TP-320, ARD-TG424,...
K992804 · ITI
Accelerated Rehab Designs, Inc.
Physical Medicine · 168d
Cleared Feb 03, 2000
E-2000 POWER ELEVATING SEAT SYSTEM, MODELS ARD-ESTORM, ARD-EP320, ARD-ELANCER
K992828 · ITI
Accelerated Rehab Designs, Inc.
Physical Medicine · 164d
Cleared Feb 03, 2000
VERSALET 7700 CARE CENTER, MODEL # 7700
K993051 · FMZ
Hill-Rom Air-Shields
General Hospital · 143d
Cleared Feb 03, 2000
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS...
K993383 · DSI
Hewlett-Packard GmbH
Cardiovascular · 118d
Cleared Feb 03, 2000
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80
K993745 · MKJ
Katecho, Inc.
Cardiovascular · 90d
Cleared Feb 03, 2000
CD HORIZON SPINAL SYSTEM
K993810 · MNH
Danek Medical, Inc.
Orthopedic · 85d