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: General Hospital ×
17,791 results
9145–9168 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 21, 1997
POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED)
K973811 · LYY
Absolute Quality Leadership, Inc.
General Hospital · 14d
Cleared Oct 20, 1997
ULTRASOUND TRANSDUCER DRAPE
K970889 · KKX
Protek Medical Products, Inc.
General Hospital · 223d
Cleared Oct 20, 1997
ULTRASOUND TRANSDUCER DRAPE
K970893 · FYA
Protek Medical Products, Inc.
General Hospital · 223d
Cleared Oct 20, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P
K972779 · MRZ
Alexander Mfg. Co.
General Hospital · 87d
Cleared Oct 20, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625
K972780 · MRZ
Alexander Mfg. Co.
General Hospital · 87d
Cleared Oct 20, 1997
REXAM FRACTURE RESISTANT POUCH
K973440 · KCT
Rexam Medical Packaging, Inc.
General Hospital · 40d
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
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 10, 1997
AUTOMIX 3+3/AS COMPOUNDER SYSTEM
K961008 · LHI
Baxter Healthcare Corp
General Hospital · 577d
Cleared Oct 10, 1997
PACER MODEL 100 INFUSION CONTROLLER
K963136 · LDR
Health Watch, Inc.
General Hospital · 423d
Cleared Oct 10, 1997
LUBRIGLIDE
K973557 · KMJ
Qualis, Inc.
General Hospital · 21d
Cleared Oct 07, 1997
MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION...
K972678 · FRN
Mcgaw, Inc.
General Hospital · 83d
Cleared Oct 03, 1997
BABYTHERM 8004 BABYTHERM 8010
K971198 · FMT
Drager, Inc.
General Hospital · 186d
Cleared Oct 03, 1997
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K972169 · LZA
Pwa Industries Sdn. Bhd.
General Hospital · 116d
Cleared Oct 02, 1997
MEDCORP FLOW I.V. REGULATOR EXTENSION SET
K971004 · FPA
Medcorp Intl.
General Hospital · 197d
Cleared Oct 02, 1997
AMSINO I.V. ADMINISTRATION SET
K973107 · FPA
Amsino Intl., Inc.
General Hospital · 44d
Cleared Oct 01, 1997
PERACT 20 LIQUID STERILANT
K960513 · MED
Minntech Corp.
General Hospital · 604d
Cleared Oct 01, 1997
CORE RESISTANT HUBER INFUSION SETS
K972712 · FPA
Icu Medical, Inc.
General Hospital · 72d
Cleared Sep 29, 1997
SA-EF MULTI-LUMEN EXTENSION SET
K972957 · FPA
Vlv Associates, Inc.
General Hospital · 49d
Cleared Sep 26, 1997
SPORTROL RAPID STERILITY INDICATOR
K962649 · MTC
North American Science Assoc., Inc.
General Hospital · 445d
Cleared Sep 26, 1997
NITRILE EXAMINATION GLOVES-PRE POWDERED
K970216 · LZA
Influx Pacific Sdn. Bhd.
General Hospital · 253d
Cleared Sep 24, 1997
DUO-LITE PHOTOTHERAPY SYSTEM
K971256 · LBI
Air-Shields, Inc.
General Hospital · 173d
Cleared Sep 24, 1997
OLYMPIC BILI-BASSINET
K971601 · LBI
Olympic Medical Corp.
General Hospital · 146d