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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,754 results
9841–9864 of 17,754
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 26, 1996
NIL LATEX POWDERFREE EXAMINATION GLOVES
K955341 · LYY
Shangrila Latex Industries Pvt. , Ltd.
General Hospital · 157d
Cleared Apr 26, 1996
PREPOWDERED LATEX EXAMINATION GLOVES
K955888 · LYY
Pantai Utama Sdn. Bhd.
General Hospital · 119d
Cleared Apr 26, 1996
POWDERFREE LATEX EXAMINATION GLOVES
K955889 · LYY
Pantai Utama Sdn. Bhd.
General Hospital · 119d
Cleared Apr 26, 1996
COMFIT ORTHOPEDIC
K960407 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 88d
Cleared Apr 26, 1996
COMFIT MICROPTIC
K960416 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 88d
Cleared Apr 26, 1996
THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER
K960572 · LJT
Arrow Intl., Inc.
General Hospital · 79d
Cleared Apr 25, 1996
TACTYLON POWDER FREE EXAMINATION GLOVE
K955464 · LZA
Tactyl Technologies, Inc.
General Hospital · 147d
Cleared Apr 25, 1996
FLUID RESISTANT MASK
K955556 · FXX
American Threshold Healthcare
General Hospital · 142d
Cleared Apr 25, 1996
FLUID REISISTANT EYESHIELD MASK
K955557 · FXX
American Threshold Healthcare
General Hospital · 142d
Cleared Apr 25, 1996
PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM
K960620 · FNM
Span-America Medical Systems, Inc.
General Hospital · 72d
Cleared Apr 23, 1996
PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE
K954824 · KKX
Medical Creative Technologies, Inc.
General Hospital · 186d
Cleared Apr 23, 1996
FREE FLOW SAFETY DEVICE
K954883 · FPA
Migada, Inc.
General Hospital · 186d
Cleared Apr 22, 1996
5 FR PICC-LINE CATHETER
K954638 · LJS
Vygon Corp.
General Hospital · 199d
Cleared Apr 22, 1996
STOPCOCK & LUER LOCK PLUG
K954970 · FMG
Medex, Inc.
General Hospital · 175d
Cleared Apr 22, 1996
SURGICAL MASK (NON-STERILE)
K955513 · FXX
United Medical Ent., Inc.
General Hospital · 140d
Cleared Apr 22, 1996
PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)
K960993 · CAK
Pall Biomedical Products Co.
General Hospital · 41d
Cleared Apr 18, 1996
UNIVEC NON-REUSABLE SYRINGE
K933469 · MEG
Univec, Inc.
General Hospital · 1007d
Cleared Apr 18, 1996
SURGICAL APPAREL
K954549 · FYC
Global Healthcare, Inc.
General Hospital · 199d
Cleared Apr 17, 1996
CELSITE PEDIATRIC VENOUS SYSTEM
K952435 · LJT
B.Braun Medical, Inc.
General Hospital · 329d
Cleared Apr 17, 1996
MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY...
K960285 · KZE
Medi-Ject Corp.
General Hospital · 89d
Cleared Apr 17, 1996
CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE
K960921 · LHI
Codan Medlon, Inc.
General Hospital · 42d
Cleared Apr 17, 1996
AREMA II
K961129 · FNM
Mellen Air Mfg., Inc.
General Hospital · 27d
Cleared Apr 15, 1996
ENTERALITE
K954735 · LZH
Zevex Intl., Inc.
General Hospital · 182d
Cleared Apr 15, 1996
GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES
K954967 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 168d