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
9049–9072 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 22, 1997
DAXOR MAX100 SYRINGE (MAX100)
K970419 · FMF
Daxor Corporation
General Hospital · 321d
Cleared Dec 22, 1997
SYNTEX
K971360 · LYZ
Shinemound Enterprise, Inc.
General Hospital · 255d
Cleared Dec 22, 1997
NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET
K971582 · LJT
Nipro Medical Corp.
General Hospital · 236d
Cleared Dec 22, 1997
CATHETER TUNNELER
K972555 · LJS
Gerard Medical, Inc.
General Hospital · 168d
Cleared Dec 22, 1997
PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95...
K974068 · MSH
Tecnol Medical Products, Inc.
General Hospital · 55d
Cleared Dec 22, 1997
TAKY-SPIKE PLUS
K974198 · LHI
Clinico
General Hospital · 42d
Cleared Dec 19, 1997
SKYVAL
K973610 · FYD
Pyramid Air Systems
General Hospital · 88d
Cleared Dec 19, 1997
COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS
K974171 · KZH
Teva Medical, Ltd.
General Hospital · 44d
Cleared Dec 18, 1997
SHANG HO
K970795 · KGO
Shang HO Industrial Corp. , Ltd.
General Hospital · 289d
Cleared Dec 18, 1997
IDA-4 AND IPT-MC
K973609 · FRN
Bio-Tek Instruments, Inc.
General Hospital · 87d
Cleared Dec 18, 1997
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K973913 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 65d
Cleared Dec 18, 1997
DASH, VITAL GARD
K974114 · LZA
Dash Medical Gloves Sdn Bhd
General Hospital · 48d
Cleared Dec 18, 1997
VINYL PATIENT EXAMINATION GLOVES (POWDERED)
K974151 · LYZ
Shanghai Super Gloves Co., Ltd.
General Hospital · 44d
Cleared Dec 18, 1997
POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K974183 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 42d
Cleared Dec 18, 1997
HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR)
K974184 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 42d
Cleared Dec 18, 1997
POLYMER NITRILE EXAMINATION GLOVES
K974185 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 42d
Cleared Dec 18, 1997
DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES
K974218 · LYY
Ansell Perry
General Hospital · 38d
Cleared Dec 18, 1997
NITRILE, POWDER FREE, POLY COATED PATIENT EXAMINATION GLOVES
K974223 · LZA
Derlin Company , Ltd.
General Hospital · 36d
Cleared Dec 18, 1997
STERITITE SEALED CONTAINERS MODEL SCO4Q
K974638 · FRG
Case Medical, Inc.
General Hospital · 69d
Cleared Dec 17, 1997
PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET
K972839 · FPA
Globe Ent., Inc.
General Hospital · 138d
Cleared Dec 17, 1997
PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S...
K972854 · FPA
Globe Ent., Inc.
General Hospital · 138d
Cleared Dec 17, 1997
VACUETTE MULTI-SAMPLE NEEDLE
K973620 · FMI
Greiner Meditech, Inc.
General Hospital · 85d
Cleared Dec 17, 1997
POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K973903 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 64d
Cleared Dec 17, 1997
POLYMER LATEX EXAMINATION GLOVES
K973904 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 64d