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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
129217–129240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1989
SYRINGE TIP ADAPTOR
K894217 · FMF
Acacia, Inc.
General Hospital · 85d
Cleared Sep 12, 1989
DAIG VESSEL DILATOR
K894330 · DRE
Daig Corp.
Cardiovascular · 60d
Cleared Sep 12, 1989
MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR
K894335 · FMF
Midmark Corp.
General Hospital · 60d
Cleared Sep 12, 1989
DISPOSABLE SHOE COVER
K894383 · FXP
American Threshold Industries, Inc.
General Hospital · 57d
Cleared Sep 12, 1989
30KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SE
K894479 · IZO
Bennett X-Ray Corp.
Radiology · 56d
Cleared Sep 12, 1989
VISOSHIELD(TM), SURGICAL EYE PROTECTOR
K894516 · FXX
Polamedco, Inc.
General Hospital · 55d
Cleared Sep 12, 1989
USCI UNCOATED GUIDING CATHETERS
K894682 · DQY
C.R. Bard, Inc.
Cardiovascular · 49d
Cleared Sep 12, 1989
IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM
K894842 · FPA
Imed Corp.
General Hospital · 43d
Cleared Sep 12, 1989
FACE PROTECTION PAK(TM)
K894905 · FXX
Protech Products
General Hospital · 42d
Cleared Sep 12, 1989
UNICARE LATEX EXAMINATION GLOVES
K894972 · LYY
Pt. Indorub Nusaraya
General Hospital · 36d
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