FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
129817–129840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1989
MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM
K894974 · LNH
Resonex, Inc.
Radiology · 36d
Cleared Sep 12, 1989
LATEX PATIENT EXAMINATION GLOVES
K894979 · LYY
Tower Rubber Industries Sdn. Bhd.
General Hospital · 35d
Cleared Sep 12, 1989
LATEX PATIENT EXAMINATION GLOVES
K894995 · LYY
Orient Commercial Co., Ltd.
General Hospital · 35d
Cleared Sep 12, 1989
KRONNER SACRAL PIN GUIDE
K895172 · LXH
Kronner Medical
Orthopedic · 33d
Cleared Sep 12, 1989
SKELETAL FIXATION PIN
K895173 · JDW
Kronner Medical
Orthopedic · 33d
Cleared Sep 12, 1989
CORTICAL SCREW
K895217 · HWC
Orthopedic Systems, Inc.
Orthopedic · 25d
Cleared Sep 12, 1989
CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MM
K895218 · HWC
Orthopedic Systems, Inc.
Orthopedic · 25d
Cleared Sep 12, 1989
CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM
K895219 · HWC
Orthopedic Systems, Inc.
Orthopedic · 25d
Cleared Sep 11, 1989
WHEELCHAIR STUMP SUPPORT
K890178 · KNN
Gerber Chair Mates, Inc.
Physical Medicine · 237d
Cleared Sep 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891509 · LYY
Delaware Industries, Inc.
General Hospital · 179d
Cleared Sep 11, 1989
PATIENT EXAM GLOVES (MFG. SHANGHAI - CHANGZHENG)
K892182 · LYY
Grand Monde Trading Co., Inc.
General Hospital · 159d
Cleared Sep 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892620 · LYY
Permark Sdn. Bhd.
General Hospital · 154d
Cleared Sep 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892623 · LYY
Globe Ent., Inc.
General Hospital · 154d
Cleared Sep 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892684 · LYY
Baldur Systems Corp.
General Hospital · 153d
Cleared Sep 11, 1989
STERILE PATIENT EXAMINATION GLOVES (LATEX)
K893095 · LYY
Asia Way Trading, Inc.
General Hospital · 153d
Cleared Sep 11, 1989
VINYL EXAMINATION GLOVES
K893100 · LYZ
Tong Shiung Plastics Industry
General Hospital · 150d
Cleared Sep 11, 1989
GLOBE PATIENT EXAMINATION GLOVES
K893159 · LYY
Lucky and Happy, Inc.
General Hospital · 150d
Cleared Sep 11, 1989
LATEX EXAMINATION GLOVES
K893279 · LYY
Safetytech Sdn. Bhd.
General Hospital · 147d
Cleared Sep 11, 1989
PROFECT EXAMINATION GLOVES
K893280 · LYY
Shanghai Latex Factory
General Hospital · 147d
Cleared Sep 11, 1989
POWDER FREE VINYL (PVC) EXAM GLOVES
K893294 · LYZ
King Handy Five Corp.
General Hospital · 146d
Cleared Sep 11, 1989
AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM W/DOPPLER
K893833 · IYN
Acoustic Imaging
Radiology · 108d
Cleared Sep 11, 1989
P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT
K893872 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 108d
Cleared Sep 11, 1989
LATEX EXAMINATION GLOVES
K893932 · LYY
Ngai Hing Latex Gloves Mfg. Co.
General Hospital · 103d
Cleared Sep 11, 1989
VKG 2000 VIDEO KERATOMETER
K893968 · HJA
Technitex, Inc.
Ophthalmic · 101d