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
91633–91656 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 1997
ISLAND BIOSURGICAL INC. BNS KIT #1 & #2
K973022 · OTN
Island Biosurgical, Inc.
Gastroenterology & Urology · 67d
Cleared Oct 20, 1997
DBEST REAGENT STRIP FOR URINALYSIS
K973142 · JIL
Ameritek, Inc.
Chemistry · 60d
Cleared Oct 20, 1997
FIRST SIGN
K973208 · LCX
Texas Immunology, Inc.
Chemistry · 54d
Cleared Oct 20, 1997
I-STAT SYSTEM
K973292 · CGL
I-Stat Corp.
Chemistry · 48d
Cleared Oct 20, 1997
REXAM FRACTURE RESISTANT POUCH
K973440 · KCT
Rexam Medical Packaging, Inc.
General Hospital · 40d
Cleared Oct 20, 1997
ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS
K973535 · KLT
Schiapparelli Biosystems, Inc.
Chemistry · 32d
Cleared Oct 20, 1997
TROPONIN (TROP) METHOD
K973650 · MMI
Dade Chemistry Systems, Inc.
Chemistry · 25d
Cleared Oct 20, 1997
CARDIAC TROPONIN-I (TROP) CALIBRATOR
K973668 · JIT
Dade Intl., Inc.
Chemistry · 25d
Cleared Oct 17, 1997
ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS
K970864 · FOZ
Arrow Intl., Inc.
General Hospital · 221d
Cleared Oct 17, 1997
SOFT TIP EPIDURAL CATHETER KIT
K971233 · CAZ
B.Braun Medical, Inc.
Anesthesiology · 198d
Cleared Oct 17, 1997
MAGI ACUPUNCTURE NEEDLES
K972658 · MQX
Dong Bang, U.S.A.
General Hospital · 94d
Cleared Oct 17, 1997
DONG BANG ACUPUNCTURE NEEDLES
K972659 · MQX
Dong Bang, U.S.A.
General Hospital · 94d
Cleared Oct 17, 1997
SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM
K972714 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 88d
Cleared Oct 17, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL9366
K972786 · DQA
Alexander Mfg. Co.
Anesthesiology · 84d
Cleared Oct 17, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P
K972787 · DRT
Alexander Mfg. Co.
Cardiovascular · 84d
Cleared Oct 17, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016
K972789 · DRT
Alexander Mfg. Co.
Cardiovascular · 84d
Cleared Oct 17, 1997
D72 DIGITAL
K972818 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 80d
Cleared Oct 17, 1997
N ANTISERUM TO HUMAN TRANSFERRIN
K972840 · DDG
Behring Diagnostics, Inc.
Immunology · 77d
Cleared Oct 17, 1997
STRAIT'MAP OPTION
K973368 · IZI
Ge Medical Systems, Inc.
Radiology · 39d
Cleared Oct 16, 1997
HARMAC BALLOON ANGIOGRAPHIC CATHETER
K962829 · DQO
Harmac Medical Products, Inc.
Cardiovascular · 475d
Cleared Oct 16, 1997
HARMAC BALLOON WEDGE PRESSURE CATHETER
K963335 · DQO
Harmac Medical Products, Inc.
Cardiovascular · 475d
Cleared Oct 16, 1997
CD SPINAL SYSTEM
K964159 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 365d
Cleared Oct 16, 1997
VARI-ANGLE HIP SCREW (VHS) SYSTEM
K964880 · KTT
Walter Abendschein, M.D.
Orthopedic · 315d
Cleared Oct 16, 1997
BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM
K970499 · DZE
Nobel Biocare Uas, Inc.
Dental · 248d