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
7993–8016 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 31, 2000
QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)
K994274 · FRN
Quest Medical, Inc.
General Hospital · 163d
Cleared May 30, 2000
NEOCARE 20 MICRON BLOOD FILTER
K000719 · CAK
Whatman, Inc.
General Hospital · 88d
Cleared May 23, 2000
NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN
K000178 · KGO
Terang Nusa Sdn Bhd
General Hospital · 124d
Cleared May 23, 2000
COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM...
K001042 · LYY
Comfort Rubber Gloves Industries Sdn....
General Hospital · 53d
Cleared May 23, 2000
GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS)
K001049 · KGO
Guthrie Medicare Products (Melaka)...
General Hospital · 53d
Cleared May 23, 2000
DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR
K001065 · LZA
Sheen More Ent. Co., Ltd.
General Hospital · 50d
Cleared May 23, 2000
NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE
K001128 · LZA
Shanghai Poseidon Plastic Products...
General Hospital · 46d
Cleared May 23, 2000
DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR
K001155 · LZA
Sheen More Ent. Co., Ltd.
General Hospital · 43d
Cleared May 23, 2000
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR...
K001190 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 41d
Cleared May 23, 2000
POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS)
K001327 · LYY
Premier Pathway Sdn. Bhd.
General Hospital · 27d
Cleared May 23, 2000
VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K994098 · LYZ
Evergreen Medical Produts (Jingxing)...
General Hospital · 172d
Cleared May 23, 2000
GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT...
K994426 · LYY
Pt. Wrp Buana Multicorpora
General Hospital · 145d
Cleared May 22, 2000
MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K000999 · LYY
Multisafe Sdn. Bhd.
General Hospital · 55d
Cleared May 17, 2000
CIDEX OPA SOLUTION
K001381 · MED
Advanced Sterilization Products
General Hospital · 15d
Cleared May 15, 2000
NUZONE NITRILE SURGICAL GLOVES POWDER FREE
K000179 · KGO
Terang Nusa Sdn Bhd
General Hospital · 116d
Cleared May 15, 2000
NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM...
K001232 · LYY
Fitco Dipped Products Pvt., Ltd.
General Hospital · 28d
Cleared May 15, 2000
ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM...
K001239 · KGO
Ansell Perry
General Hospital · 27d
Cleared May 15, 2000
COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH...
K001280 · LYY
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 24d
Cleared May 15, 2000
STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI...
K001444 · JOJ
Steritec Products, Inc.
General Hospital · 7d
Cleared May 15, 2000
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200...
K993760 · LYY
Hartalega Sdn Bhd
General Hospital · 189d
Cleared May 12, 2000
PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER
K001368 · LHI
Carmel Pharma Ab.
General Hospital · 11d
Cleared May 10, 2000
POSI-LINK
K000472 · FPA
Icu Medical, Inc.
General Hospital · 86d
Cleared May 09, 2000
PSK ENDOSCOPE CLEANING SYSTEM
K000216 · FEB
Psk Connectors Pty, Ltd.
General Hospital · 106d
Cleared May 09, 2000
GO MEDICAL BALLOON INFUSION SYSTEM
K000263 · MEB
Go Medical Industries Pty. , Ltd.
General Hospital · 102d