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
96769–96792 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1996
HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
K960749 · JBP
International Technidyne Corp.
Hematology · 171d
Cleared Aug 12, 1996
STOP-N-GROW
K960843 · MQZ
European Touch Co., Inc.
General & Plastic Surgery · 165d
Cleared Aug 12, 1996
DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40
K961869 · DTM
Sorin Biomedical, Inc.
Cardiovascular · 89d
Cleared Aug 12, 1996
EXTRAHAND BALLOON RETRACTOR
K962005 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 82d
Cleared Aug 12, 1996
3M DENT SYSTEM
K962785 · KLE
3M Company
Dental · 26d
Cleared Aug 09, 1996
FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS
K955563 · LPH
Encore Orthopedics, Inc.
Orthopedic · 247d
Cleared Aug 09, 1996
NOBELPHARMA BONE ANCHORED HEARING AID
K955713 · LXB
Nobelpharma USA, Inc.
Ear, Nose, Throat · 235d
Cleared Aug 09, 1996
EAGLE PATIENT MONITOR MODEL 3000/3100
K961139 · DSI
Marquette Electronics, Inc.
Cardiovascular · 141d
Cleared Aug 09, 1996
HEAD RETAINING DEVICE
K961467 · IYE
S. and H. Engineering, Inc.
Radiology · 116d
Cleared Aug 09, 1996
DEPUY DISPOSABLE FILTER/HOOD
K961791 · LYU
Depuy, Inc.
General Hospital · 92d
Cleared Aug 09, 1996
SPR PLUS II OVERLAY SYSTEM (CL250/CL212
K961854 · FNM
Gaymar Industries, Inc.
General Hospital · 87d
Cleared Aug 09, 1996
POLAR CARE (MODEL 500/50000)
K961855 · ILO
Breg, Inc.
Physical Medicine · 87d
Cleared Aug 09, 1996
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
K961872 · KPI
Hollister, Inc.
Gastroenterology & Urology · 86d
Cleared Aug 09, 1996
RDP-2
K961922 · HET
Ranfac, Corp.
Obstetrics & Gynecology · 84d
Cleared Aug 09, 1996
RE-NEW LAPAROSCOPIC INSTRUMENTS
K962119 · GEI
Microline Pentax, Inc.
General & Plastic Surgery · 70d
Cleared Aug 09, 1996
SELECT SHOULDER KEELED ALL-POLY GLENOIDS
K962238 · KWT
Intermedics Orthopedics
Orthopedic · 59d
Cleared Aug 09, 1996
SELECT SHOULDER PEGGED ALL-POLY GLENOID
K962244 · KWT
Intermedics Orthopedics
Orthopedic · 59d
Cleared Aug 09, 1996
SINGLE USE INSTRUMENT TRAY
K962328 · FSM
Medcare Medical Group, Inc.
General & Plastic Surgery · 64d
Cleared Aug 09, 1996
OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200)
K962380 · EOQ
Olympus America, Inc.
Ear, Nose, Throat · 50d
Cleared Aug 09, 1996
PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH
K962530 · FTL
Ethicon, Inc.
General & Plastic Surgery · 42d
Cleared Aug 09, 1996
OLYPUS FG SERIES GRASPING FORCEPS
K962533 · EOQ
Olympus America, Inc.
Ear, Nose, Throat · 42d
Cleared Aug 09, 1996
REXAM SELF-SEAL TYVEK POUCH
K962600 · KCT
Rexam Medical Packaging, Inc.
General Hospital · 38d
Cleared Aug 09, 1996
MONTGOMERY RADIOPAQUE LARYNGEAL KEEL
K962693 · FWN
Boston Medical Products, Inc.
Ear, Nose, Throat · 29d
Cleared Aug 09, 1996
MT10P, MT60-PP, MT60-AGC0, AND MT60
K962847 · ESD
Micro-Tech Hearing Instruments
Ear, Nose, Throat · 18d